Accutrend Plus Meter Kit

FDA UDI

Class II (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name: Accutrend Plus Meter Kit FDA UDI
Generic Name: Point-of-care blood glucose monitoring system FDA UDI
Model / Reference: 07769202001 FDA UDI

Identifiers

Catalog Number: 07769202001 FDA UDI
Primary DI / UDI-DI: 04015630946365 FDA UDI
510(k) Number: K051376 FDA UDI
FDA Product Code: CGA FDA UDI
GMDN Term: Point-of-care blood glucose monitoring system 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

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Point-of-care blood glucose monitoring system

Accutrend Plus Meter Kit by Roche Diagnostics Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Point-of-care blood glucose monitoring system.

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Accu-Chek Inform II Base Unit — Roche Diagnostics Corp. · Class II
Accu-Chek Inform II Base Unit — Roche Diagnostics Corp. · Class II
Accutrend Plus Meter Kit — Roche Diagnostics Corp. · Class II
Accu-Chek Inform II Instrument with RF card — Roche Diagnostics Corp. · Class II

Cleared under the same submission

K051376 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Roche Diagnostics Corp.

Sources (1)

FDA UDI 4802aeba-2a05-4dc6-92ea-ad0de8411ea6 35 fields · synced Jun 8, 2026