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FDA 510(k)

UNIFAST GAMMA-GT

K-Number: K873135 · 1987-09-04

ApplicantSclavo, Inc.
Decision Date1987-09-04
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UNIFAST GAMMA-GT is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1987-09-04 under 510(k) number K873135. 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 UNIFAST GAMMA-GT?

UNIFAST GAMMA-GT is a medical device that received FDA 510(k) clearance on 1987-09-04. The listed applicant is Sclavo, Inc.. The 510(k) number is K873135.

When did UNIFAST GAMMA-GT receive FDA 510(k) clearance?

UNIFAST GAMMA-GT received FDA 510(k) clearance on 1987-09-04, under 510(k) number K873135.

Who is the listed applicant for UNIFAST GAMMA-GT?

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

What is the FDA product code for UNIFAST GAMMA-GT?

The FDA product code for UNIFAST GAMMA-GT is JQB.

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Other records listing Sclavo, 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.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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