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FDA 510(k)

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43

K-Number: K914464 · 1991-11-22

ApplicantEm Diagnostic Systems, Inc.
Decision Date1991-11-22
Product CodeCKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 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 1991-11-22 under 510(k) number K914464. 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 ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43?

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 is a medical device that received FDA 510(k) clearance on 1991-11-22. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K914464.

When did ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 receive FDA 510(k) clearance?

ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 received FDA 510(k) clearance on 1991-11-22, under 510(k) number K914464.

Who is the listed applicant for ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43?

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 ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43?

The FDA product code for ABBOTT QUICKSTART SGPT, ITEM NUMBER 5A43 is CKA.

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Other records listing Em Diagnostic Systems, Inc. as applicant

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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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