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FDA 510(k)

BCS GLUCOSE COLORIMETRIC TEST

K-Number: K850257 · 1985-03-05

ApplicantBioclinical Systems, Inc.
Decision Date1985-03-05
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BCS GLUCOSE COLORIMETRIC TEST is the device name listed in this FDA 510(k) record. The listed applicant is Bioclinical Systems, Inc.. It received FDA 510(k) clearance on 1985-03-05 under 510(k) number K850257. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BCS GLUCOSE COLORIMETRIC TEST?

BCS GLUCOSE COLORIMETRIC TEST is a medical device that received FDA 510(k) clearance on 1985-03-05. The listed applicant is Bioclinical Systems, Inc.. The 510(k) number is K850257.

When did BCS GLUCOSE COLORIMETRIC TEST receive FDA 510(k) clearance?

BCS GLUCOSE COLORIMETRIC TEST received FDA 510(k) clearance on 1985-03-05, under 510(k) number K850257.

Who is the listed applicant for BCS GLUCOSE COLORIMETRIC TEST?

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

What is the FDA product code for BCS GLUCOSE COLORIMETRIC TEST?

The FDA product code for BCS GLUCOSE COLORIMETRIC TEST is CGA.

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Other records listing Bioclinical Systems, Inc. as applicant

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Related Devices (Code: CGA)

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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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