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FDA 510(k)

AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT

K-Number: K780783 · 1978-06-06

ApplicantJ.T. Baker Chemical Co.
Decision Date1978-06-06
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT 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 1978-06-06 under 510(k) number K780783. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT?

AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT is a medical device that received FDA 510(k) clearance on 1978-06-06. The listed applicant is J.T. Baker Chemical Co.. The 510(k) number is K780783.

When did AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT receive FDA 510(k) clearance?

AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT received FDA 510(k) clearance on 1978-06-06, under 510(k) number K780783.

Who is the listed applicant for AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT?

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 CHOLESTEROL-OXIDASE REAGENT KIT?

The FDA product code for AUTOZYME CHOLESTEROL-OXIDASE REAGENT KIT is CHH.

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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: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

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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