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FDA 510(k)

REAGENT SET HDL CHOLESTEROL

K-Number: K780635 · 1978-05-19

ApplicantBoehringer Mannheim Corp.
Decision Date1978-05-19
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

REAGENT SET HDL CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Boehringer Mannheim Corp.. It received FDA 510(k) clearance on 1978-05-19 under 510(k) number K780635. 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 HDL CHOLESTEROL?

REAGENT SET HDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1978-05-19. The listed applicant is Boehringer Mannheim Corp.. The 510(k) number is K780635.

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

REAGENT SET HDL CHOLESTEROL received FDA 510(k) clearance on 1978-05-19, under 510(k) number K780635.

Who is the listed applicant for REAGENT SET HDL CHOLESTEROL?

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

What is the FDA product code for REAGENT SET HDL CHOLESTEROL?

The FDA product code for REAGENT SET HDL CHOLESTEROL is CHH.

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Other records listing Boehringer Mannheim Corp. as applicant

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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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