FDA 510(k)

ASPARTATE AMINOTRANSFERASE (AST) TEST

K-Number: K935181 · 1994-01-27

Decision Date1994-01-27

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

ASPARTATE AMINOTRANSFERASE (AST) TEST is the device name listed in this FDA 510(k) record. The listed applicant is Em Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1994-01-27 under 510(k) number K935181. 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 (AST) TEST?

ASPARTATE AMINOTRANSFERASE (AST) TEST is a medical device that received FDA 510(k) clearance on 1994-01-27. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K935181.

When did ASPARTATE AMINOTRANSFERASE (AST) TEST receive FDA 510(k) clearance?

ASPARTATE AMINOTRANSFERASE (AST) TEST received FDA 510(k) clearance on 1994-01-27, under 510(k) number K935181.

Who is the listed applicant for ASPARTATE AMINOTRANSFERASE (AST) TEST?

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

What is the FDA product code for ASPARTATE AMINOTRANSFERASE (AST) TEST?

The FDA product code for ASPARTATE AMINOTRANSFERASE (AST) TEST is CIT.

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Other records listing Em Diagnostic Systems, Inc. as applicant

K935180ALANINE AMINOTRANSFERASE (ALT) TEST K935178EMDS PHOSPHOROUS (PHOS) TEST K935179EMDS ALBUMIN (ALB) TEST K935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)K935176IRON TEST

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Related Devices (Code: CIT)

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 GmbH K071525ACTIVATED ASPARTATE AMINOTRANSFERASEAbbott Laboratories K071580AST/GOT (IFCC), PYRIDOXAL PHOSPHATE, ECAL, NORTROL AND ABTROLThermofisher Scientific OY K071211COBAS C 111 ANALYZERRoche Diagnostics K060318HEPATIC ENZYMES ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZERHoriba Abx

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.