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FDA 510(k)

ENZYMATICS, INC., TOTAL CHOLESTEROL TEST

K-Number: K911692 · 1991-08-16

ApplicantEnzymatics C/O Burditt,Bowles,Radzius & Ruberry
Decision Date1991-08-16
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATICS, INC., TOTAL CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. It received FDA 510(k) clearance on 1991-08-16 under 510(k) number K911692. 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 ENZYMATICS, INC., TOTAL CHOLESTEROL TEST?

ENZYMATICS, INC., TOTAL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1991-08-16. The listed applicant is Enzymatics C/O Burditt,Bowles,Radzius & Ruberry. The 510(k) number is K911692.

When did ENZYMATICS, INC., TOTAL CHOLESTEROL TEST receive FDA 510(k) clearance?

ENZYMATICS, INC., TOTAL CHOLESTEROL TEST received FDA 510(k) clearance on 1991-08-16, under 510(k) number K911692.

Who is the listed applicant for ENZYMATICS, INC., TOTAL CHOLESTEROL TEST?

The FDA 510(k) record lists Enzymatics C/O Burditt,Bowles,Radzius & Ruberry as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENZYMATICS, INC., TOTAL CHOLESTEROL TEST?

The FDA product code for ENZYMATICS, INC., TOTAL CHOLESTEROL TEST is CHH.

Related Clinical Trials

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.

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Other records listing Enzymatics C/O Burditt,Bowles,Radzius & Ruberry 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.

K903235STATLAB A-350 SALIVA ALCOHOL TESTK894001SALIVA ALCOHOL TEST

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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