A.P. Total Care, Inc.

United StatesFDA 510(k) applicant, unverified

Devices: 18

What A.P. Total Care, Inc. makes

A.P. Total Care, Inc. manufactures in vitro diagnostic reagents for measuring blood chemistry parameters, including uric acid, LDL cholesterol, carbon dioxide, magnesium, alkaline phosphatase, albumin, electrolytes (sodium, potassium, chloride), blood urea nitrogen (BUN), bilirubin (total and direct), total iron, fructosamine, and calcium buffers with EDTA reagents.

The company’s portfolio consists of Class I and Class II in vitro diagnostic devices, all listed via the FDA’s 510(k) pathway. These products are intended for laboratory use in the United States.

AI-generated from registry data, 1 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

Newest first, rows 1-18 of 18

Search and filter all 18 devices

Uric Acid, Model UA112-01 Ref K991247

Class I

Active 510(k) 510(k) I
Ldl Cholesterol, Product No's, 124-01, CH102-01 Ref K991664

Class I

Active 510(k) 510(k) I
Carbon Dioxide (CO2), Product No. CC0107-01 Ref K991108

Class II

Active 510(k) 510(k) II
Magnesium Product No's, 112-01, 112-02 Ref K991761

Class I

Active 510(k) 510(k) I
Alkaline Phophatase (Alp), Product No's 118-01, 118-02 Ref K991762

Class II

Active 510(k) 510(k) II
Albumin Bcg, Model Al 103-01 Ref K990978

Class II

Active 510(k) 510(k) II
Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03 Ref K991870

Class II

Active 510(k) 510(k) II
Bun, Model Bu 104-01 Ref K990980

Class II

Active 510(k) 510(k) II
Bilirubin, Total And Direct, Product No, 122-01, 122-02, 122-03, 122-04 Ref K991866

Class II

Active 510(k) 510(k) II
Total Iron, Models Fe 109-01, Fe 109-02 Ref K991244

Class I

Active 510(k) 510(k) I
Fructosamine, Model Fr 106-01 Ref K991246

Class II

Active 510(k) 510(k) II
Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02 Ref K991111

Class II

Active 510(k) 510(k) II
Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02 Ref K991666

Class I

Active 510(k) 510(k) I
Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02 Ref K991867

Class I

Active 510(k) 510(k) I
Ast/Sgot Ref K991663

Class II

Active 510(k) 510(k) II
Hdl Cholesterol, Product No's 124-01, CH102-01 Ref K991665

Class I

Active 510(k) 510(k) I
Glucose, Hexokinase (R1), Model GL101-01, Glucose Hexokinase (R2), Model GL101-02 Ref K990981

Class II

Active 510(k) 510(k) II
Creatinine Reagent, Product No CR105-01, Creatinine Reagent, Product No CR105-02 Ref K991109

Class II

Active 510(k) 510(k) II

Rows 1-18 of 18

Frequently asked questions

How many devices does A.P. Total Care, Inc. have in the registry?

The registry currently lists 18 devices for A.P. Total Care, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list A.P. Total Care, Inc.'s devices?

Among its 18 most recently registered devices, A.P. Total Care, Inc. has devices listed in FDA 510(k) (18 devices).

What risk classes do A.P. Total Care, Inc.'s devices fall under?

Among its 18 most recently registered devices, the classes recorded for A.P. Total Care, Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from A.P. Total Care, Inc. in the registry?

The most recently registered devices listed for A.P. Total Care, Inc. include URIC ACID, MODEL UA112-01, LDL CHOLESTEROL, PRODUCT NO'S, 124-01, CH102-01, CARBON DIOXIDE (CO2), PRODUCT NO. CC0107-01 and MAGNESIUM PRODUCT NO'S, 112-01, 112-02.

Generated automatically from registry data and not verified by a human reviewer.

What A.P. Total Care, Inc. makes

Catalogue18

Uric Acid, Model UA112-01 Ref K991247

Ldl Cholesterol, Product No's, 124-01, CH102-01 Ref K991664

Carbon Dioxide (CO2), Product No. CC0107-01 Ref K991108

Magnesium Product No's, 112-01, 112-02 Ref K991761

Alkaline Phophatase (Alp), Product No's 118-01, 118-02 Ref K991762

Albumin Bcg, Model Al 103-01 Ref K990978

Electrolytes (Na+, K+, Cl-), Product No's 114-01, 114-02, 114-03 Ref K991870

Bun, Model Bu 104-01 Ref K990980

Bilirubin, Total And Direct, Product No, 122-01, 122-02, 122-03, 122-04 Ref K991866

Total Iron, Models Fe 109-01, Fe 109-02 Ref K991244

Fructosamine, Model Fr 106-01 Ref K991246

Buffer Chromogen (R1), Product No. CA110-01, Edta Reagen (R2), Product No. CA110-02 Ref K991111

Tibc, Product No's 123-0, 123-02, FE109-01, FE109-02 Ref K991666

Inorganic Phosphorus (Ip), Product No's, 112-01, 112-02 Ref K991867

Ast/Sgot Ref K991663

Hdl Cholesterol, Product No's 124-01, CH102-01 Ref K991665

Glucose, Hexokinase (R1), Model GL101-01, Glucose Hexokinase (R2), Model GL101-02 Ref K990981

Creatinine Reagent, Product No CR105-01, Creatinine Reagent, Product No CR105-02 Ref K991109

Frequently asked questions