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FDA 510(k)

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60

K-Number: K961282 · 1996-06-21

ApplicantDiagnostic Chemicals , Ltd.
Decision Date1996-06-21
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 1996-06-21 under 510(k) number K961282. 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 GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60?

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 is a medical device that received FDA 510(k) clearance on 1996-06-21. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K961282.

When did GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 receive FDA 510(k) clearance?

GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 received FDA 510(k) clearance on 1996-06-21, under 510(k) number K961282.

Who is the listed applicant for GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60?

The FDA product code for GLUCOSE-SL ASSAY, CATALOGUE NO. 235-60 is CFR.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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