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FDA 510(k)

DART GAMMA-GT REAGENT SYSTEM

K-Number: K834054 · 1984-02-04

ApplicantCoulter Electronics, Inc.
Decision Date1984-02-04
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DART GAMMA-GT REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1984-02-04 under 510(k) number K834054. 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 DART GAMMA-GT REAGENT SYSTEM?

DART GAMMA-GT REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1984-02-04. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K834054.

When did DART GAMMA-GT REAGENT SYSTEM receive FDA 510(k) clearance?

DART GAMMA-GT REAGENT SYSTEM received FDA 510(k) clearance on 1984-02-04, under 510(k) number K834054.

Who is the listed applicant for DART GAMMA-GT REAGENT SYSTEM?

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

What is the FDA product code for DART GAMMA-GT REAGENT SYSTEM?

The FDA product code for DART GAMMA-GT REAGENT SYSTEM is JQB.

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Other records listing Coulter Electronics, Inc. as applicant

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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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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.K964457ROCHE COBAS IBTEGRA REAGENT CASSETTESRoche Diagnostic Systems, Inc.K964916GAMMA-GLUTAMYL TRANSPEPTIDASEDerma Media Lab., Inc.K955770GAMMA GLUTAMYL TRANSFERASE TEST SYSTEMAbaxis, 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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