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On Call Pro Glucose Control Solution Kit

FDA UDI

Class I (US FDA UDI)

by ACON Laboratories, Inc.

Identity

Trade Name
On Call Pro Glucose Control Solution Kit FDA UDI
Generic Name
Glucose monitoring system IVD, point-of-care FDA UDI
Device Name
Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 FDA UDI
Model / Reference
G125-12L FDA UDI
Description
Glucose Control Solution Kit includes 2mL Control 0, 2mL Control 1, 2mL Control 2 FDA UDI

Identifiers

Primary DI / UDI-DI
00682607558315 FDA UDI
510(k) Number
K161867 FDA UDI
FDA Product Code
JJX FDA UDI
GMDN Term
Glucose monitoring system IVD, point-of-care FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.1660 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

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 Glucose Control Solution Kit by ACON Laboratories, Inc. — Class I — 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 ecd0d0f6-4dbc-47e9-8999-ae2f8f3deb95 36 fields · synced Jun 9, 2026