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FDA 510(k)

ROCHE COBAS IBTEGRA REAGENT CASSETTES

K-Number: K964457 · 1997-01-13

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1997-01-13
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROCHE COBAS IBTEGRA REAGENT CASSETTES 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 1997-01-13 under 510(k) number K964457. The device is classified under product code JQB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROCHE COBAS IBTEGRA REAGENT CASSETTES?

ROCHE COBAS IBTEGRA REAGENT CASSETTES is a medical device that received FDA 510(k) clearance on 1997-01-13. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K964457.

When did ROCHE COBAS IBTEGRA REAGENT CASSETTES receive FDA 510(k) clearance?

ROCHE COBAS IBTEGRA REAGENT CASSETTES received FDA 510(k) clearance on 1997-01-13, under 510(k) number K964457.

Who is the listed applicant for ROCHE COBAS IBTEGRA REAGENT CASSETTES?

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 ROCHE COBAS IBTEGRA REAGENT CASSETTES?

The FDA product code for ROCHE COBAS IBTEGRA REAGENT CASSETTES is JQB.

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Other records listing Roche Diagnostic Systems, Inc. as applicant

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Related Devices (Code: JQB)

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.

K974000Y-GLUTAMYLTRANSFERASE-SL ASSAY , CATALOGE NUMBER 324-10, 324-30Diagnostic Chemicals , Ltd.K973157LIQUID GGT (GAMMA GLUTAMYL TRANSFERASE) REAGENT SETPointe Scientific, Inc.,K971466SYNCHRON CX SYSTEMS GAMMA-GLUTAMYL TRANSFERASE REAGENT (GGT)Carolina Liquid Chemistries Corp.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, Inc.K945800Y-GLUTAMYLTRANSFERASE ASSAY, CATALOGUE NUMBER 308-05Diagnostic Chemicals , Ltd.

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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