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FDA 510(k)

CHOLESTEROL-E (FREE)

K-Number: K863064 · 1986-09-11

ApplicantJ. D. Assoc.
Decision Date1986-09-11
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL-E (FREE) is the device name listed in this FDA 510(k) record. The listed applicant is J. D. Assoc.. It received FDA 510(k) clearance on 1986-09-11 under 510(k) number K863064. 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 CHOLESTEROL-E (FREE)?

CHOLESTEROL-E (FREE) is a medical device that received FDA 510(k) clearance on 1986-09-11. The listed applicant is J. D. Assoc.. The 510(k) number is K863064.

When did CHOLESTEROL-E (FREE) receive FDA 510(k) clearance?

CHOLESTEROL-E (FREE) received FDA 510(k) clearance on 1986-09-11, under 510(k) number K863064.

Who is the listed applicant for CHOLESTEROL-E (FREE)?

The FDA 510(k) record lists J. D. Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL-E (FREE)?

The FDA product code for CHOLESTEROL-E (FREE) is CHH.

Related Clinical Trials

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Other records listing J. D. Assoc. 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.

K863054AST S.C.E. (GOT)K863103PEG 6,000K863069MAGNESIOMETERK863079CREATINKINETICK863112PROTEINMETERK863053ALT S.C.E. (GPT)

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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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