Buffer Chromogen (R1), Product No. CA110-01, EDTA Reagen (R2), Product No. CA110-02

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K991111 ↗

FDA Product Code

CIC

Device Class

Class II

Regulation

21 CFR Part 862.1145

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Uric Acid, Model UA112-01

  Class I

  FDA 510(k) K991247 Active Cleared 25 May 1999

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  FDA 510(k) K991664 Active Cleared 19 Aug 1999

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

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  FDA 510(k) K991108 Active Cleared 25 May 1999

• Magnesium Product No's, 112-01, 112-02

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  FDA 510(k) K991761 Active Cleared 2 Sep 1999

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

  Class II

  FDA 510(k) K991762 Active Cleared 2 Sep 1999

• Albumin Bcg, Model Al 103-01

  Class II

  FDA 510(k) K990978 Active Cleared 25 May 1999

See all devices from A.P. Total Care, Inc. →

• What are the Buffer Chromogen (R1) and EDTA Reagen (R2) used for?

  These are in vitro diagnostic reagents specifically designed for calcium measurement in clinical chemistry laboratories. They are classified as Cresolphthalein Complexone, Calcium (product code CIC) and are supplied as two separate components.

• How are these reagents supplied and what is their regulatory status?

  The Buffer Chromogen (R1), Product No. CA110-01 and EDTA Reagen (R2), Product No. CA110-02 are supplied as two separate reagents. They are regulated under FDA 510(k) clearance K991111 with a Class II designation and manufactured by A.P. Total Care, Inc.

• Are these reagents single-use or reusable?

  The device information does not specify whether these reagents are single-use or reusable. This detail should be confirmed with the manufacturer directly or through the product documentation before use in clinical settings.

• What applications are these reagents intended for?

  These reagents are intended for use in clinical chemistry laboratories for calcium measurement applications. They are not indicated for other laboratory procedures or diagnostic purposes outside of calcium measurement.