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FDA 510(k)

SIGMA 58-UV ASPARTATE AMINOTRANSFERAS

K-Number: K842411 · 1984-08-12

ApplicantSigma Chemical Co.
Decision Date1984-08-12
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SIGMA 58-UV ASPARTATE AMINOTRANSFERAS 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 1984-08-12 under 510(k) number K842411. The device is classified under product code CIT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA 58-UV ASPARTATE AMINOTRANSFERAS?

SIGMA 58-UV ASPARTATE AMINOTRANSFERAS is a medical device that received FDA 510(k) clearance on 1984-08-12. The listed applicant is Sigma Chemical Co.. The 510(k) number is K842411.

When did SIGMA 58-UV ASPARTATE AMINOTRANSFERAS receive FDA 510(k) clearance?

SIGMA 58-UV ASPARTATE AMINOTRANSFERAS received FDA 510(k) clearance on 1984-08-12, under 510(k) number K842411.

Who is the listed applicant for SIGMA 58-UV ASPARTATE AMINOTRANSFERAS?

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 SIGMA 58-UV ASPARTATE AMINOTRANSFERAS?

The FDA product code for SIGMA 58-UV ASPARTATE AMINOTRANSFERAS is CIT.

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Other records listing Sigma Chemical Co. as applicant

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Related Devices (Code: CIT)

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.

K093883AST/GOT 4+1 SL, AST/GOT 4+1 SL, ELICAL 2, ELITROL I, ELITROL II, MODEL ASSL-0250, ASSL-0455, CALI-0580, CONT-0080, CONT-Seppim S.A.S.K080485ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FSDiasys Diagnostics Systems GmbHK071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott LaboratoriesK071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OYK071211COBAS C 111 ANALYZERRoche DiagnosticsK060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

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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