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FDA 510(k)

LIPID PROFILE

K-Number: K813469 · 1981-12-31

ApplicantBio-Analytics Laboratories, Inc.
Decision Date1981-12-31
Product CodeCFD
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LIPID PROFILE is the device name listed in this FDA 510(k) record. The listed applicant is Bio-Analytics Laboratories, Inc.. It received FDA 510(k) clearance on 1981-12-31 under 510(k) number K813469. The device is classified under product code CFD. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LIPID PROFILE?

LIPID PROFILE is a medical device that received FDA 510(k) clearance on 1981-12-31. The listed applicant is Bio-Analytics Laboratories, Inc.. The 510(k) number is K813469.

When did LIPID PROFILE receive FDA 510(k) clearance?

LIPID PROFILE received FDA 510(k) clearance on 1981-12-31, under 510(k) number K813469.

Who is the listed applicant for LIPID PROFILE?

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

What is the FDA product code for LIPID PROFILE?

The FDA product code for LIPID PROFILE is CFD.

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Other records listing Bio-Analytics Laboratories, 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.

K861638KINETIC ALKALINE PHOSPHATASE REAGENT KITK860245ENZYMATIC ALPHA-AMYLASE REAGENT KITK860213ALBUMIN REAGENT KITK851513ULTRA-VIOLET BUN REAGENT KITK851514ULTRA-VIOLET GLUCOSE REAGENTK850639ENZYMATIC ALPHA-AMYLASE REAGENT KIT

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Related Devices (Code: CFD)

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.

K863073TOTAL LIPIDSJ. D. Assoc.K860112TOTAL LIPIDS REAGENT SETTechnostics Intl.K820500TOTAL LIPID REAGENT SETAnco Medical Reagents & Assoc.

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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