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FDA 510(k)

LACTATE DEHYDROGENASE (LD) PROCEDURE

K-Number: K861662 · 1986-05-29

ApplicantData Medical Associates, Inc.
Decision Date1986-05-29
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LACTATE DEHYDROGENASE (LD) PROCEDURE 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 1986-05-29 under 510(k) number K861662. 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 (LD) PROCEDURE?

LACTATE DEHYDROGENASE (LD) PROCEDURE is a medical device that received FDA 510(k) clearance on 1986-05-29. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K861662.

When did LACTATE DEHYDROGENASE (LD) PROCEDURE receive FDA 510(k) clearance?

LACTATE DEHYDROGENASE (LD) PROCEDURE received FDA 510(k) clearance on 1986-05-29, under 510(k) number K861662.

Who is the listed applicant for LACTATE DEHYDROGENASE (LD) PROCEDURE?

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 (LD) PROCEDURE?

The FDA product code for LACTATE DEHYDROGENASE (LD) PROCEDURE is CFJ.

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Other records listing Data Medical Associates, 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.

K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955302SERUM BICARBONATE/CARBON DIOXIDEK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955300TOTAL BILIRUBIN PROCEDURE

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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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