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FDA 510(k)

ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV

K-Number: K954839 · 1996-01-05

ApplicantSigma Diagnostics, Inc.
Decision Date1996-01-05
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-01-05 under 510(k) number K954839. 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 ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV?

ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV is a medical device that received FDA 510(k) clearance on 1996-01-05. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K954839.

When did ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV receive FDA 510(k) clearance?

ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV received FDA 510(k) clearance on 1996-01-05, under 510(k) number K954839.

Who is the listed applicant for ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV?

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

What is the FDA product code for ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV?

The FDA product code for ASPARTATE AMINOTRANSFERASE PROCEDURE NO.. 58-UV is CIT.

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Other records listing Sigma Diagnostics, 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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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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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