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FDA 510(k)

DATA-ZYME TRIGLYCERIDE PROCEDURE

K-Number: K780379 · 1978-05-12

ApplicantData Medical Associates, Inc.
Decision Date1978-05-12
Product CodeCDT
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DATA-ZYME TRIGLYCERIDE 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 1978-05-12 under 510(k) number K780379. The device is classified under product code CDT. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-ZYME TRIGLYCERIDE PROCEDURE?

DATA-ZYME TRIGLYCERIDE PROCEDURE is a medical device that received FDA 510(k) clearance on 1978-05-12. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K780379.

When did DATA-ZYME TRIGLYCERIDE PROCEDURE receive FDA 510(k) clearance?

DATA-ZYME TRIGLYCERIDE PROCEDURE received FDA 510(k) clearance on 1978-05-12, under 510(k) number K780379.

Who is the listed applicant for DATA-ZYME TRIGLYCERIDE 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 DATA-ZYME TRIGLYCERIDE PROCEDURE?

The FDA product code for DATA-ZYME TRIGLYCERIDE PROCEDURE is CDT.

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Other records listing Data Medical Associates, Inc. as applicant

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K993098HDL-C/LDL-C CALIBRATOR, MODEL 1913-003K971113DMA TRIGLYCERIDES PROCEDURESK961919DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDUREK955796IRON CALIBRATOR & CALIBRATION VERIFICATION SETK955302SERUM BICARBONATE/CARBON DIOXIDEK955300TOTAL BILIRUBIN PROCEDURE

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Related Devices (Code: CDT)

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.

K133067ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENTSiemens Healthcare Diagnostics, Inc.K130332VITROS CHEMISTRY PRODUCTS TRIG SLIDESOrtho-Clinical Diagnostics, Inc.K113830VANTERA CLINICAL ANALYZERLiposcienceK102993ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SLSeppim S.A.S.K063804OLYMPUS TRIGLYCERIDE TEST SYSTEMOlympus America, Inc.K043546DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULEDade Behring, Inc.

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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