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FDA 510(k)

LACTATE DEHYDROGENASE TEST (LD) ITEM #65418

K-Number: K894482 · 1989-09-07

ApplicantEm Diagnostic Systems, Inc.
Decision Date1989-09-07
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 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 1989-09-07 under 510(k) number K894482. The device is classified under product code CFJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTATE DEHYDROGENASE TEST (LD) ITEM #65418?

LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 is a medical device that received FDA 510(k) clearance on 1989-09-07. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K894482.

When did LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 receive FDA 510(k) clearance?

LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 received FDA 510(k) clearance on 1989-09-07, under 510(k) number K894482.

Who is the listed applicant for LACTATE DEHYDROGENASE TEST (LD) ITEM #65418?

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 LACTATE DEHYDROGENASE TEST (LD) ITEM #65418?

The FDA product code for LACTATE DEHYDROGENASE TEST (LD) ITEM #65418 is CFJ.

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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: CFJ)

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.

K131975ACE DIRECT TOTAL IRON-BINDING CAPACITY (TIBC) REAGENT, ACE TOTAL IRON REAGENT, ACE LDH-L REAGENTAlfa Wassermann Diagnostic Technologies, Inc.K091544S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017Alfa Wassermann, Inc.K051108PICCOLO LACTATE DEPHYDROGENASE TEST SYSTEMAbaxis, Inc.K974859LACTANE DEHYDROGENASE-SL ASSAY, CATALOGUE NUMBER 327-10, 327-30Diagnostic Chemicals , Ltd.K973589LIQUID LDH-L REAGENT SETPointe Scientific, Inc.,K970684LACTATE DEHYDROGENASE (LD)Randox Laboratories, Ltd.

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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