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FDA 510(k)

COULTER GAMMA-GT (GGT) REAGENT

K-Number: K901264 · 1990-04-16

ApplicantCoulter Corp.
Decision Date1990-04-16
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

COULTER GAMMA-GT (GGT) REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Corp.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K901264. 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 COULTER GAMMA-GT (GGT) REAGENT?

COULTER GAMMA-GT (GGT) REAGENT is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Coulter Corp.. The 510(k) number is K901264.

When did COULTER GAMMA-GT (GGT) REAGENT receive FDA 510(k) clearance?

COULTER GAMMA-GT (GGT) REAGENT received FDA 510(k) clearance on 1990-04-16, under 510(k) number K901264.

Who is the listed applicant for COULTER GAMMA-GT (GGT) REAGENT?

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

What is the FDA product code for COULTER GAMMA-GT (GGT) REAGENT?

The FDA product code for COULTER GAMMA-GT (GGT) REAGENT is JQB.

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Other records listing Coulter Corp. 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.

K993356COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSESK991070COULTER Z2 ANALYZERK990327RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMSK990172TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLAK990352COULTER AC T DIFF 2 ANALYZERK984216IMMUNO-TROL CONTROL CELLS

View all 51 devices →

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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