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FDA 510(k)

LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE

K-Number: K864360 · 1987-02-06

ApplicantTrace Scientific , Ltd.
Decision Date1987-02-06
Product Code
DecisionSubstantially Equivalent

Device Summary

LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE is the device name listed in this FDA 510(k) record. The listed applicant is Trace Scientific , Ltd.. It received FDA 510(k) clearance on 1987-02-06 under 510(k) number K864360. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE?

LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE is a medical device that received FDA 510(k) clearance on 1987-02-06. The listed applicant is Trace Scientific , Ltd.. The 510(k) number is K864360.

When did LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE receive FDA 510(k) clearance?

LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE received FDA 510(k) clearance on 1987-02-06, under 510(k) number K864360.

Who is the listed applicant for LDH-P (LACTIC DEHYDROGENASE) REAGENT - SCE?

The FDA 510(k) record lists Trace Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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Other records listing Trace Scientific , Ltd. 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.

K982121ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENTK981123UREAK962890CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)K961114AST INCORPORATING DSTK961123ALT INCORPORATING DSTK952488TRACE COBAS MIRA RANGE

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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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