Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

DMA LD KINETIC PROCEDURE

K-Number: K915803 · 1992-03-18

ApplicantData Medical Associates, Inc.
Decision Date1992-03-18
Product CodeCFJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DMA LD KINETIC 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 1992-03-18 under 510(k) number K915803. 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 DMA LD KINETIC PROCEDURE?

DMA LD KINETIC PROCEDURE is a medical device that received FDA 510(k) clearance on 1992-03-18. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K915803.

When did DMA LD KINETIC PROCEDURE receive FDA 510(k) clearance?

DMA LD KINETIC PROCEDURE received FDA 510(k) clearance on 1992-03-18, under 510(k) number K915803.

Who is the listed applicant for DMA LD KINETIC 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 DMA LD KINETIC PROCEDURE?

The FDA product code for DMA LD KINETIC PROCEDURE is CFJ.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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) PROCEDUREK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955302SERUM BICARBONATE/CARBON DIOXIDEK955300TOTAL BILIRUBIN PROCEDURE

View all 111 devices →

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.

↑