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FDA 510(k)

FLOW-PAC GGT REAGENT SET

K-Number: K833029 · 1983-12-29

ApplicantAmerican Research Products Co.
Decision Date1983-12-29
Product CodeJQB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FLOW-PAC GGT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is American Research Products Co.. It received FDA 510(k) clearance on 1983-12-29 under 510(k) number K833029. 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 FLOW-PAC GGT REAGENT SET?

FLOW-PAC GGT REAGENT SET is a medical device that received FDA 510(k) clearance on 1983-12-29. The listed applicant is American Research Products Co.. The 510(k) number is K833029.

When did FLOW-PAC GGT REAGENT SET receive FDA 510(k) clearance?

FLOW-PAC GGT REAGENT SET received FDA 510(k) clearance on 1983-12-29, under 510(k) number K833029.

Who is the listed applicant for FLOW-PAC GGT REAGENT SET?

The FDA 510(k) record lists American Research Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FLOW-PAC GGT REAGENT SET?

The FDA product code for FLOW-PAC GGT REAGENT SET is JQB.

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Other records listing American Research Products Co. 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.

K942984BUN REAGENTK901527BIURET (COLORMETRIC), TOTAL PROTEINK901960IRON REAGENTS PRODUCT CODES 7725 AND 7726K901964PHOSPHORUS REAGENTS PROD CODES 7763/7764/7563/7463K900827COLORIMETRIC CHLORIDE PRODUCT #4314125K901702NAD REDUCTION, ALT/SPGT CODES 7722,7723,7422,7522

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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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