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FDA 510(k)

ULTRAZYME PLUS & SYSTEMATE LDH

K-Number: K854585 · 1985-12-05

ApplicantEm Diagnostic Systems, Inc.
Decision Date1985-12-05
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ULTRAZYME PLUS & SYSTEMATE LDH 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 1985-12-05 under 510(k) number K854585. 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 ULTRAZYME PLUS & SYSTEMATE LDH?

ULTRAZYME PLUS & SYSTEMATE LDH is a medical device that received FDA 510(k) clearance on 1985-12-05. The listed applicant is Em Diagnostic Systems, Inc.. The 510(k) number is K854585.

When did ULTRAZYME PLUS & SYSTEMATE LDH receive FDA 510(k) clearance?

ULTRAZYME PLUS & SYSTEMATE LDH received FDA 510(k) clearance on 1985-12-05, under 510(k) number K854585.

Who is the listed applicant for ULTRAZYME PLUS & SYSTEMATE LDH?

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 ULTRAZYME PLUS & SYSTEMATE LDH?

The FDA product code for ULTRAZYME PLUS & SYSTEMATE LDH 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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