FDA 510(k)

DMA GLUCOSE HEXOKINASE U.V. PROCEDURE

K-Number: K952437 · 1995-10-03

Decision Date1995-10-03

Product CodeCFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DMA GLUCOSE HEXOKINASE U.V. 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 1995-10-03 under 510(k) number K952437. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DMA GLUCOSE HEXOKINASE U.V. PROCEDURE?

DMA GLUCOSE HEXOKINASE U.V. PROCEDURE is a medical device that received FDA 510(k) clearance on 1995-10-03. The listed applicant is Data Medical Associates, Inc.. The 510(k) number is K952437.

When did DMA GLUCOSE HEXOKINASE U.V. PROCEDURE receive FDA 510(k) clearance?

DMA GLUCOSE HEXOKINASE U.V. PROCEDURE received FDA 510(k) clearance on 1995-10-03, under 510(k) number K952437.

Who is the listed applicant for DMA GLUCOSE HEXOKINASE U.V. 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 GLUCOSE HEXOKINASE U.V. PROCEDURE?

The FDA product code for DMA GLUCOSE HEXOKINASE U.V. PROCEDURE is CFR.

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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.