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FDA 510(k)

EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95

K-Number: K863963 · 1986-11-28

ApplicantEm Diagnostic Systems, Inc.
Decision Date1986-11-28
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 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 1986-11-28 under 510(k) number K863963. 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 EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95?

EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 is a medical device that received FDA 510(k) clearance on 1986-11-28. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K863963.

When did EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 receive FDA 510(k) clearance?

EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 received FDA 510(k) clearance on 1986-11-28, under 510(k) number K863963.

Who is the listed applicant for EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95?

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 EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95?

The FDA product code for EMDS(TM) ASPARTATE AMINOTRANSFERASE (AST) 67657/95 is CIT.

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Other records listing Em Diagnostic Systems, 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.

K935181ASPARTATE AMINOTRANSFERASE (AST) TESTK935180ALANINE AMINOTRANSFERASE (ALT) TESTK935178EMDS PHOSPHOROUS (PHOS) TESTK935179EMDS ALBUMIN (ALB) TESTK935175LACTATE DEHYDROGENASE (LD)K935174TOTAL PROTEIN TEST (TPRO)

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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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