FDA 510(k)

GLUCOSE REAGENT B6360-11

K-Number: K831634 · 1983-07-19

Decision Date1983-07-19

Product CodeCGA

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

GLUCOSE REAGENT B6360-11 is the device name listed in this FDA 510(k) record. The listed applicant is American Scientific Products. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831634. 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 GLUCOSE REAGENT B6360-11?

GLUCOSE REAGENT B6360-11 is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is American Scientific Products. The 510(k) number is K831634.

When did GLUCOSE REAGENT B6360-11 receive FDA 510(k) clearance?

GLUCOSE REAGENT B6360-11 received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831634.

Who is the listed applicant for GLUCOSE REAGENT B6360-11?

The FDA 510(k) record lists American Scientific Products as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLUCOSE REAGENT B6360-11?

The FDA product code for GLUCOSE REAGENT B6360-11 is 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.