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FDA 510(k)

FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)

K-Number: K862507 · 1986-07-16

ApplicantSclavo, Inc.
Decision Date1986-07-16
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) is the device name listed in this FDA 510(k) record. The listed applicant is Sclavo, Inc.. It received FDA 510(k) clearance on 1986-07-16 under 510(k) number K862507. 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 FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)?

FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) is a medical device that received FDA 510(k) clearance on 1986-07-16. The listed applicant is Sclavo, Inc.. The 510(k) number is K862507.

When did FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) receive FDA 510(k) clearance?

FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) received FDA 510(k) clearance on 1986-07-16, under 510(k) number K862507.

Who is the listed applicant for FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)?

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

What is the FDA product code for FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST)?

The FDA product code for FAST CHOLESTEROL (TOTAL CHOLESTEROL TEST) is CHH.

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Other records listing Sclavo, 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.

K914789ELISA CMV IGMK914852ELISA TOXO IGMK914420ELISA RUBELLA IGMK895943NORMAL AND ABNORMAL CONTROL SERAK895822TOTAL BILIRUBIN L.F.K895847CREATININE 340 (ENZYMATIC)

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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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