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FDA 510(k)

ENZYMATIC CHOLESTEROL

K-Number: K771820 · 1977-10-19

ApplicantMacomb Chemical Co.
Decision Date1977-10-19
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZYMATIC CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Macomb Chemical Co.. It received FDA 510(k) clearance on 1977-10-19 under 510(k) number K771820. 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 ENZYMATIC CHOLESTEROL?

ENZYMATIC CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1977-10-19. The listed applicant is Macomb Chemical Co.. The 510(k) number is K771820.

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

ENZYMATIC CHOLESTEROL received FDA 510(k) clearance on 1977-10-19, under 510(k) number K771820.

Who is the listed applicant for ENZYMATIC CHOLESTEROL?

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

What is the FDA product code for ENZYMATIC CHOLESTEROL?

The FDA product code for ENZYMATIC CHOLESTEROL is CHH.

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Other records listing Macomb 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.

K830095RAPID CHEM ANALYZER IIK823720SPECTROPHOTOMETERK810958GLYCOHEMOGLOBINK801086P-NITROPHENYL PHOSPHATEK800719ENZYMATIC UREA NITROGEN REAGENT SET REVIK800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEO

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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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