FDA 510(k)

GLUCOSE KIT

K-Number: K761320 · 1977-01-25

ApplicantEnvironmental Chemical Specialties

Decision Date1977-01-25

Product CodeCFR

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOSE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Environmental Chemical Specialties. It received FDA 510(k) clearance on 1977-01-25 under 510(k) number K761320. 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 KIT?

GLUCOSE KIT is a medical device that received FDA 510(k) clearance on 1977-01-25. The listed applicant is Environmental Chemical Specialties. The 510(k) number is K761320.

When did GLUCOSE KIT receive FDA 510(k) clearance?

GLUCOSE KIT received FDA 510(k) clearance on 1977-01-25, under 510(k) number K761320.

Who is the listed applicant for GLUCOSE KIT?

The FDA 510(k) record lists Environmental Chemical Specialties as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE KIT?

The FDA product code for GLUCOSE KIT 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.