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FDA 510(k)

ALT/GPT REAGENT SET

K-Number: K844251 · 1985-01-08

ApplicantSterling Biochemical, Inc.
Decision Date1985-01-08
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT/GPT REAGENT SET is the device name listed in this FDA 510(k) record. The listed applicant is Sterling Biochemical, Inc.. It received FDA 510(k) clearance on 1985-01-08 under 510(k) number K844251. 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 ALT/GPT REAGENT SET?

ALT/GPT REAGENT SET is a medical device that received FDA 510(k) clearance on 1985-01-08. The listed applicant is Sterling Biochemical, Inc.. The 510(k) number is K844251.

When did ALT/GPT REAGENT SET receive FDA 510(k) clearance?

ALT/GPT REAGENT SET received FDA 510(k) clearance on 1985-01-08, under 510(k) number K844251.

Who is the listed applicant for ALT/GPT REAGENT SET?

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

What is the FDA product code for ALT/GPT REAGENT SET?

The FDA product code for ALT/GPT REAGENT SET is CKA.

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Other records listing Sterling Biochemical, 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.

K844998GLUCOSE(HEXOKINASE) REAGENT SETK843332ALKALINE PHOSPHATASE REAGENT SETK842521AST/GOT REAGENT SET UV RATEK840064UREA NITROGEN REAGENT SETK834084HYDROXYBUTYRATE DEHYDROGENASE REAGENTK834045URIC ACID REAGENT SET

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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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