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FDA 510(k)

SYSTEMATE LDH, 67210

K-Number: K843269 · 1984-09-13

ApplicantEm Diagnostic Systems, Inc.
Decision Date1984-09-13
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SYSTEMATE LDH, 67210 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 1984-09-13 under 510(k) number K843269. 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 SYSTEMATE LDH, 67210?

SYSTEMATE LDH, 67210 is a medical device that received FDA 510(k) clearance on 1984-09-13. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K843269.

When did SYSTEMATE LDH, 67210 receive FDA 510(k) clearance?

SYSTEMATE LDH, 67210 received FDA 510(k) clearance on 1984-09-13, under 510(k) number K843269.

Who is the listed applicant for SYSTEMATE LDH, 67210?

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 SYSTEMATE LDH, 67210?

The FDA product code for SYSTEMATE LDH, 67210 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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