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FDA 510(k)

CHOLESTEROL & HDL CHOL. PROCEDURE

K-Number: K781165 · 1978-07-27

ApplicantData Medical Associates, Inc.
Decision Date1978-07-27
Product Code
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL & HDL CHOL. 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 1978-07-27 under 510(k) number K781165. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHOLESTEROL & HDL CHOL. PROCEDURE?

CHOLESTEROL & HDL CHOL. PROCEDURE is a medical device that received FDA 510(k) clearance on 1978-07-27. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K781165.

When did CHOLESTEROL & HDL CHOL. PROCEDURE receive FDA 510(k) clearance?

CHOLESTEROL & HDL CHOL. PROCEDURE received FDA 510(k) clearance on 1978-07-27, under 510(k) number K781165.

Who is the listed applicant for CHOLESTEROL & HDL CHOL. PROCEDURE?

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

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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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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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