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cobas c 501 Module

FDA UDI

Class I (US FDA UDI)

by Roche Diagnostics Corp.

Identity

Trade Name
cobas c 501 Module FDA UDI
Generic Name
Multiple clinical chemistry analyser IVD, laboratory FDA UDI
Model / Reference
4745914001 FDA UDI

Identifiers

Catalog Number
4745914001 FDA UDI
Primary DI / UDI-DI
04015630924707 FDA UDI
510(k) Number
K060373 FDA UDI
FDA Product Code
JJF FDA UDI
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
862.2170 FDA UDI
Commercial Distribution
Not 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

No

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

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

cobas c 501 Module by Roche Diagnostics Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K060373 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Roche Diagnostics Corp.

Sources (1)

  • FDA UDI b52381ec-e82f-4181-b6dc-83f48e269cf6 35 fields · synced May 30, 2026