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FDA 510(k)

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403

K-Number: K893752 · 1989-07-20

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-07-20
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 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 1989-07-20 under 510(k) number K893752. 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 ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403?

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 is a medical device that received FDA 510(k) clearance on 1989-07-20. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K893752.

When did ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 receive FDA 510(k) clearance?

ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 received FDA 510(k) clearance on 1989-07-20, under 510(k) number K893752.

Who is the listed applicant for ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403?

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 ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403?

The FDA product code for ALANINE AMINOTRANSFERASE TEST (ALT) ITEM # 65403 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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