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FDA 510(k)

CHOLESTEROL METHOD

K-Number: K852863 · 1985-07-23

ApplicantCatachem, Inc.
Decision Date1985-07-23
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Catachem, Inc.. It received FDA 510(k) clearance on 1985-07-23 under 510(k) number K852863. 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 CHOLESTEROL METHOD?

CHOLESTEROL METHOD is a medical device that received FDA 510(k) clearance on 1985-07-23. The listed applicant is Catachem, Inc.. The 510(k) number is K852863.

When did CHOLESTEROL METHOD receive FDA 510(k) clearance?

CHOLESTEROL METHOD received FDA 510(k) clearance on 1985-07-23, under 510(k) number K852863.

Who is the listed applicant for CHOLESTEROL METHOD?

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

What is the FDA product code for CHOLESTEROL METHOD?

The FDA product code for CHOLESTEROL METHOD is CHH.

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Other records listing Catachem, Inc. 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.

K062503CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KITK945408340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZERK932871UIBC FOR DISCREET RANDOM ACCESS ANALYZERK903341MAGNESIUMK902326AMYLASE FOR MANUAL/AUTOMATED APPLICATIONSK902877TOTAL IRON FOR MANUAL/AUTOMATED

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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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