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FDA 510(k)

HDL-CHOLESTEROL PRECIPITATING REAGENT

K-Number: K883543 · 1988-12-16

ApplicantMedical Analysis Systems, Inc.
Decision Date1988-12-16
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-CHOLESTEROL PRECIPITATING REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Medical Analysis Systems, Inc.. It received FDA 510(k) clearance on 1988-12-16 under 510(k) number K883543. 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 HDL-CHOLESTEROL PRECIPITATING REAGENT?

HDL-CHOLESTEROL PRECIPITATING REAGENT is a medical device that received FDA 510(k) clearance on 1988-12-16. The listed applicant is Medical Analysis Systems, Inc.. The 510(k) number is K883543.

When did HDL-CHOLESTEROL PRECIPITATING REAGENT receive FDA 510(k) clearance?

HDL-CHOLESTEROL PRECIPITATING REAGENT received FDA 510(k) clearance on 1988-12-16, under 510(k) number K883543.

Who is the listed applicant for HDL-CHOLESTEROL PRECIPITATING REAGENT?

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

What is the FDA product code for HDL-CHOLESTEROL PRECIPITATING REAGENT?

The FDA product code for HDL-CHOLESTEROL PRECIPITATING REAGENT is CHH.

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Other records listing Medical Analysis Systems, 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.

K042717MAS, DADE AND LIQUID ASSAYED DIABETES CONTROLK041194ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND HK040880MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3K032826MAS PAR TDMK032335MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TLK031890MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL

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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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