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FDA 510(k)

LACTATE DEHYDROGENASE ISOENZYME 1

K-Number: K872891 · 1987-09-16

ApplicantData Medical Associates, Inc.
Decision Date1987-09-16
Product CodeCEX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE ISOENZYME 1 is the device name listed in this FDA 510(k) record. The listed applicant is Data Medical Associates, Inc.. It received FDA 510(k) clearance on 1987-09-16 under 510(k) number K872891. The device is classified under product code CEX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LACTATE DEHYDROGENASE ISOENZYME 1?

LACTATE DEHYDROGENASE ISOENZYME 1 is a medical device that received FDA 510(k) clearance on 1987-09-16. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K872891.

When did LACTATE DEHYDROGENASE ISOENZYME 1 receive FDA 510(k) clearance?

LACTATE DEHYDROGENASE ISOENZYME 1 received FDA 510(k) clearance on 1987-09-16, under 510(k) number K872891.

Who is the listed applicant for LACTATE DEHYDROGENASE ISOENZYME 1?

The FDA 510(k) record lists Data Medical Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LACTATE DEHYDROGENASE ISOENZYME 1?

The FDA product code for LACTATE DEHYDROGENASE ISOENZYME 1 is CEX.

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Other records listing Data Medical Associates, Inc. as applicant

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Related Devices (Code: CEX)

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.

K851521LD-1(IMMUNO) SEPARATION SETSeragen Diagnostics, Inc.K842018ISO-SEP SYSTEMBerwick Medical Products, Inc.K821983TITAN GEL LDH ISOENZYME KITHelena LaboratoriesK821879ULTRACHEM T.P.Harleco DiagnosticsK800129CENTRIFICHEM CREATININEUnion Carbide Corp.K772356LDH ISOENZYME COLUMN REAGENT SETWorthington Biochemical Corp.

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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