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FDA 510(k)

REAGENT SET, CHOLESTEROL, CAT NO. 4024

K-Number: K770747 · 1977-06-01

ApplicantAmerican Monitor Corp.
Decision Date1977-06-01
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SET, CHOLESTEROL, CAT NO. 4024 is the device name listed in this FDA 510(k) record. The listed applicant is American Monitor Corp.. It received FDA 510(k) clearance on 1977-06-01 under 510(k) number K770747. 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 REAGENT SET, CHOLESTEROL, CAT NO. 4024?

REAGENT SET, CHOLESTEROL, CAT NO. 4024 is a medical device that received FDA 510(k) clearance on 1977-06-01. The listed applicant is American Monitor Corp.. The 510(k) number is K770747.

When did REAGENT SET, CHOLESTEROL, CAT NO. 4024 receive FDA 510(k) clearance?

REAGENT SET, CHOLESTEROL, CAT NO. 4024 received FDA 510(k) clearance on 1977-06-01, under 510(k) number K770747.

Who is the listed applicant for REAGENT SET, CHOLESTEROL, CAT NO. 4024?

The FDA 510(k) record lists American Monitor Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REAGENT SET, CHOLESTEROL, CAT NO. 4024?

The FDA product code for REAGENT SET, CHOLESTEROL, CAT NO. 4024 is CHH.

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Other records listing American Monitor Corp. 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.

K896000ASPARTATE AMINOTRANFERASE (AST)K895999PHOSPHORUSK896001ALANINE AMINOTRANSFERASE (ALT)K895423ACCESS CHEMISTRY ANALYZERK893137EXCEL (TM) CHEMISTRY ANALYZERK892331ENZYMATIC UREA NITROGEN REAGENT SET

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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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