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FDA 510(k)

AMES/GILFORD OPTIMATE CLIN. CHEM & THER

K-Number: K821583 · 1982-06-24

ApplicantGilford Instrument Laboratories, Inc.
Decision Date1982-06-24
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AMES/GILFORD OPTIMATE CLIN. CHEM & THER is the device name listed in this FDA 510(k) record. The listed applicant is Gilford Instrument Laboratories, Inc.. It received FDA 510(k) clearance on 1982-06-24 under 510(k) number K821583. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMES/GILFORD OPTIMATE CLIN. CHEM & THER?

AMES/GILFORD OPTIMATE CLIN. CHEM & THER is a medical device that received FDA 510(k) clearance on 1982-06-24. The listed applicant is Gilford Instrument Laboratories, Inc.. The 510(k) number is K821583.

When did AMES/GILFORD OPTIMATE CLIN. CHEM & THER receive FDA 510(k) clearance?

AMES/GILFORD OPTIMATE CLIN. CHEM & THER received FDA 510(k) clearance on 1982-06-24, under 510(k) number K821583.

Who is the listed applicant for AMES/GILFORD OPTIMATE CLIN. CHEM & THER?

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

What is the FDA product code for AMES/GILFORD OPTIMATE CLIN. CHEM & THER?

The FDA product code for AMES/GILFORD OPTIMATE CLIN. CHEM & THER is JJF.

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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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