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FDA 510(k)

COBAS READY ALT REAGENT

K-Number: K896237 · 1990-02-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1990-02-16
Product CodeCKD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COBAS READY ALT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1990-02-16 under 510(k) number K896237. The device is classified under product code CKD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COBAS READY ALT REAGENT?

COBAS READY ALT REAGENT is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K896237.

When did COBAS READY ALT REAGENT receive FDA 510(k) clearance?

COBAS READY ALT REAGENT received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896237.

Who is the listed applicant for COBAS READY ALT REAGENT?

The FDA 510(k) record lists Roche Diagnostic Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COBAS READY ALT REAGENT?

The FDA product code for COBAS READY ALT REAGENT is CKD.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: CKD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772Cholestech Corp.K941192ORTHO ALT MICROWELL TEST SYSTEMOrtho Diagnostic Systems, Inc.K884784VIRGO(R) MICROWELL ALT ASSAYElectro-Nucleonics, Inc.K883387ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD)Tech-Co, Inc.K864082REFLOTRON(R) ALT (GPT)Boehringer Mannheim Corp.K860485SGPT (ALT) REAGENT SET (COLORIMETRIC)Sterling Diagnostics, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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