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On Call Pro Blood Glucose Test Strips

FDA UDI

Class II (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
On Call Pro Blood Glucose Test Strips FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
Blood Glucose Test Strips, box of 50 strips FDA UDI
Model / Reference
G135-10L FDA UDI
Description
Blood Glucose Test Strips, box of 50 strips FDA UDI

Identifiers

Primary DI / UDI-DI
00682607558216 FDA UDI
510(k) Number
K161867 FDA UDI
FDA Product Code
CGA FDA UDI
GMDN Term
Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
862.1345 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Glucose monitoring system IVD, home-useGlucose monitoring system IVD, point-of-care

On Call Pro Blood Glucose Test Strips by ACON Laboratories, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Glucose monitoring system IVD, point-of-care.

Cleared under the same submission

K161867 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
ACON Laboratories, Inc.

Sources (1)

  • FDA UDI db39d04e-b74c-4de5-9444-c67eb1f2011d 36 fields · synced Jun 9, 2026