FDA 510(k)

EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010

K-Number: K874600 · 1988-01-21

Decision Date1988-01-21

Product CodeCIT

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 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 1988-01-21 under 510(k) number K874600. 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 EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010?

EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 is a medical device that received FDA 510(k) clearance on 1988-01-21. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K874600.

When did EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 receive FDA 510(k) clearance?

EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 received FDA 510(k) clearance on 1988-01-21, under 510(k) number K874600.

Who is the listed applicant for EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010?

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 EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010?

The FDA product code for EASY-TEST ASPARTATE AMINOTRANSFERASE (ASAT) #19010 is CIT.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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.