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FDA 510(k)

DYNAZYME II GPT 340

K-Number: K771152 · 1977-11-03

ApplicantJ.T. Baker Chemical Co.
Decision Date1977-11-03
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DYNAZYME II GPT 340 is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1977-11-03 under 510(k) number K771152. 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 DYNAZYME II GPT 340?

DYNAZYME II GPT 340 is a medical device that received FDA 510(k) clearance on 1977-11-03. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K771152.

When did DYNAZYME II GPT 340 receive FDA 510(k) clearance?

DYNAZYME II GPT 340 received FDA 510(k) clearance on 1977-11-03, under 510(k) number K771152.

Who is the listed applicant for DYNAZYME II GPT 340?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNAZYME II GPT 340?

The FDA product code for DYNAZYME II GPT 340 is CKA.

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Other records listing J.T. Baker Chemical Co. as applicant

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K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.K801661J.T. BAKER CERULOPLASMIN NEPHELOMETRIC

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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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