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FDA 510(k)

REAGENT GPT, ENZYME

K-Number: K770314 · 1977-03-30

ApplicantIcn Pharmaceuticals, Inc.
Decision Date1977-03-30
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT GPT, ENZYME is the device name listed in this FDA 510(k) record. The listed applicant is Icn Pharmaceuticals, Inc.. It received FDA 510(k) clearance on 1977-03-30 under 510(k) number K770314. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REAGENT GPT, ENZYME?

REAGENT GPT, ENZYME is a medical device that received FDA 510(k) clearance on 1977-03-30. The listed applicant is Icn Pharmaceuticals, Inc.. The 510(k) number is K770314.

When did REAGENT GPT, ENZYME receive FDA 510(k) clearance?

REAGENT GPT, ENZYME received FDA 510(k) clearance on 1977-03-30, under 510(k) number K770314.

Who is the listed applicant for REAGENT GPT, ENZYME?

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

What is the FDA product code for REAGENT GPT, ENZYME?

The FDA product code for REAGENT GPT, ENZYME is CKA.

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Other records listing Icn Pharmaceuticals, Inc. as applicant

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Related Devices (Code: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, 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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