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FDA 510(k)

APOLIPOPROTEIN B (APO B)

K-Number: K900124 · 1990-03-02

ApplicantSigma Chemical Co.
Decision Date1990-03-02
Product CodeDEL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN B (APO B) is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Chemical Co.. It received FDA 510(k) clearance on 1990-03-02 under 510(k) number K900124. The device is classified under product code DEL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the APOLIPOPROTEIN B (APO B)?

APOLIPOPROTEIN B (APO B) is a medical device that received FDA 510(k) clearance on 1990-03-02. The listed applicant is Sigma Chemical Co.. The 510(k) number is K900124.

When did APOLIPOPROTEIN B (APO B) receive FDA 510(k) clearance?

APOLIPOPROTEIN B (APO B) received FDA 510(k) clearance on 1990-03-02, under 510(k) number K900124.

Who is the listed applicant for APOLIPOPROTEIN B (APO B)?

The FDA 510(k) record lists Sigma Chemical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for APOLIPOPROTEIN B (APO B)?

The FDA product code for APOLIPOPROTEIN B (APO B) is DEL.

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Other records listing Sigma Chemical Co. 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.

K933694SIGMA GLUCOSE REAGENTK933678SIGMA CALCIUM REAGENTK933696SIGMA ELECTROLYTE REFERENCE REAGENTK933691SIGMA CO2 ALKALINE BUFFER REAGENTK933679SIGMA BUN REAGENTK933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: DEL)

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.

K013278TINA-QUANT APOLIPOPROTEIN A-1 VER.2Roche Diagnostics Corp.K901675APOLIPOPROTEIN A-I (APO A-I)Sigma Chemical Co.K895160ORTHO *APO A-1 ELISA TEST SYSTEMMedical Marketing Consultants, Inc.K893885BACTON TM, BASIC TM, APO A-I REAGENTCatachem, 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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