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FDA 510(k)

ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)

K-Number: K871782 · 1987-05-26

ApplicantBiochemical Trade, Inc.
Decision Date1987-05-26
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) is the device name listed in this FDA 510(k) record. The listed applicant is Biochemical Trade, Inc.. It received FDA 510(k) clearance on 1987-05-26 under 510(k) number K871782. 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 ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)?

ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) is a medical device that received FDA 510(k) clearance on 1987-05-26. The listed applicant is Biochemical Trade, Inc.. The 510(k) number is K871782.

When did ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) receive FDA 510(k) clearance?

ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) received FDA 510(k) clearance on 1987-05-26, under 510(k) number K871782.

Who is the listed applicant for ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)?

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

What is the FDA product code for ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT)?

The FDA product code for ULTRAVIOLET ALANINE AMINO-TRANS (UV-ALT/UV-GPT) is CKA.

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Other records listing Biochemical Trade, Inc. 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.

K942958CREATINE KINASE MB DETERMINATION (UV)K910635TOTAL BILIRUBIN REAGENT SETK910296PHOSPHORUS (INORGANIC) TEST SYSTEMK905776ALBUMIN REAGENT SETK905790TOTAL PROTEIN REAGENT SETK905650KINETIC ALKALINE PHOSPHATASE DETERMINATION

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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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