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FDA 510(k)

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405

K-Number: K893692 · 1989-08-21

ApplicantDiagnostic Systems
Decision Date1989-08-21
Product CodeCIT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems. It received FDA 510(k) clearance on 1989-08-21 under 510(k) number K893692. 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 ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405?

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 is a medical device that received FDA 510(k) clearance on 1989-08-21. The listed applicant is Diagnostic Systems. The 510(k) number is K893692.

When did EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 receive FDA 510(k) clearance?

EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 received FDA 510(k) clearance on 1989-08-21, under 510(k) number K893692.

Who is the listed applicant for EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405?

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

What is the FDA product code for EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405?

The FDA product code for EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405 is CIT.

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Other records listing Diagnostic Systems 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.

K905146OLYMPUS URINE PHK893691EMDS CREATINE KINASE ITEM NIMBER 65411K893966HDL PRECIPITATING REAGENTK884993VISUAL BLOOD GLUCOSE TEST SYSTEMK881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641K880787EASY-TEST LACTIC ACID (LA)

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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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