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FDA 510(k)

AUTOZYME GLUCOSE OXIDASE (TRINDER)

K-Number: K772308 · 1978-03-03

ApplicantJ.T. Baker Chemical Co.
Decision Date1978-03-03
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOZYME GLUCOSE OXIDASE (TRINDER) is the device name listed in this FDA 510(k) record. The listed applicant is J.T. Baker Chemical Co.. It received FDA 510(k) clearance on 1978-03-03 under 510(k) number K772308. 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 AUTOZYME GLUCOSE OXIDASE (TRINDER)?

AUTOZYME GLUCOSE OXIDASE (TRINDER) is a medical device that received FDA 510(k) clearance on 1978-03-03. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K772308.

When did AUTOZYME GLUCOSE OXIDASE (TRINDER) receive FDA 510(k) clearance?

AUTOZYME GLUCOSE OXIDASE (TRINDER) received FDA 510(k) clearance on 1978-03-03, under 510(k) number K772308.

Who is the listed applicant for AUTOZYME GLUCOSE OXIDASE (TRINDER)?

The FDA 510(k) record lists J.T. Baker Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AUTOZYME GLUCOSE OXIDASE (TRINDER)?

The FDA product code for AUTOZYME GLUCOSE OXIDASE (TRINDER) is CGA.

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Other records listing J.T. Baker Chemical Co. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K803128SERIES 810 PLATELET ANALYZERK802080BAKER DIAG. ULTRARATE CHLORIDE KITK801909LSA 290 ASSAY REAGENTS/NEPHELOMETRICK802035BAKER DIAG. ULTRARATE CO2 REAGENT KITK801661J.T. BAKER CERULOPLASMIN NEPHELOMETRICK801795BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT.

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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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