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FDA 510(k)

ALT REAGENT (PROCEDURE NUMBER 159)

K-Number: K893560 · 1989-07-20

ApplicantSigma Chemical Co.
Decision Date1989-07-20
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALT REAGENT (PROCEDURE NUMBER 159) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1989-07-20 under 510(k) number K893560. 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 REAGENT (PROCEDURE NUMBER 159)?

ALT REAGENT (PROCEDURE NUMBER 159) is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Sigma Chemical Co.. The 510(k) number is K893560.

When did ALT REAGENT (PROCEDURE NUMBER 159) receive FDA 510(k) clearance?

ALT REAGENT (PROCEDURE NUMBER 159) received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893560.

Who is the listed applicant for ALT REAGENT (PROCEDURE NUMBER 159)?

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

What is the FDA product code for ALT REAGENT (PROCEDURE NUMBER 159)?

The FDA product code for ALT REAGENT (PROCEDURE NUMBER 159) is CKA.

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Other records listing Sigma Chemical 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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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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