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FDA 510(k)

MULTICHEM ENZYMATIC CHOLESTEROL SYS

K-Number: K831700 · 1983-07-19

ApplicantSimmler, Inc.
Decision Date1983-07-19
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MULTICHEM ENZYMATIC CHOLESTEROL SYS is the device name listed in this FDA 510(k) record. The listed applicant is Simmler, Inc.. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831700. 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 MULTICHEM ENZYMATIC CHOLESTEROL SYS?

MULTICHEM ENZYMATIC CHOLESTEROL SYS is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Simmler, Inc.. The 510(k) number is K831700.

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

MULTICHEM ENZYMATIC CHOLESTEROL SYS received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831700.

Who is the listed applicant for MULTICHEM ENZYMATIC CHOLESTEROL SYS?

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

What is the FDA product code for MULTICHEM ENZYMATIC CHOLESTEROL SYS?

The FDA product code for MULTICHEM ENZYMATIC CHOLESTEROL SYS is CHH.

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Other records listing Simmler, 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.

K895745SICKLE CELL SOLUBILITY TEST KITK874903MULTICHEM(R) Y -GLUTAMYLTRANSFERASE (Y -GT)K874595MULTICHEM (R) MAGNESIUM REAGENTK874820MULTICHEM HDL PRECIPITATING REAGENT #S0914K874812MULTICHEM CHLORIDE REAGENT S0933K874311MULTICHEM (R) TOTAL BILIRUBIN

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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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