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FDA 510(k)

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017

K-Number: K874586 · 1988-01-21

ApplicantEm Diagnostic Systems, Inc.
Decision Date1988-01-21
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 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 K874586. The device is classified under product code CKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017?

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 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 K874586.

When did EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 receive FDA 510(k) clearance?

EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 received FDA 510(k) clearance on 1988-01-21, under 510(k) number K874586.

Who is the listed applicant for EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017?

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 ALANINE AMINOTRANSFERASE (ALAT) #19017?

The FDA product code for EASY-TEST ALANINE AMINOTRANSFERASE (ALAT) #19017 is CKA.

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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: CKA)

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.

K120945HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ASTHitachi Chemical Diagnostics, Inc.K113382ACE ALT REAGENTAlfa WassermannK061020DIMENSION VISTA ALBUMIN, ALKALINE PHOSPHATASE, ASPARTATE AMINO TRANSFERASE, CARBAMAZEPINE & ALANINE AMINO TRANSFERASEDade Behring, Inc.K020487CARESIDE ALTCareside, Inc.K980028ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST)Trace America, Inc.K973869TRACE REAGENT LINE FOR THE COBAS MIRATrace America, Inc.

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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