FDA 510(k)

APOLIPOPROTEIN A-I (APO A-I)

K-Number: K901675 · 1990-04-26

Decision Date1990-04-26

Product CodeDEL

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

APOLIPOPROTEIN A-I (APO A-I) 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 1990-04-26 under 510(k) number K901675. 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 A-I (APO A-I)?

APOLIPOPROTEIN A-I (APO A-I) is a medical device that received FDA 510(k) clearance on 1990-04-26. The listed applicant is Sigma Chemical Co.. The 510(k) number is K901675.

When did APOLIPOPROTEIN A-I (APO A-I) receive FDA 510(k) clearance?

APOLIPOPROTEIN A-I (APO A-I) received FDA 510(k) clearance on 1990-04-26, under 510(k) number K901675.

Who is the listed applicant for APOLIPOPROTEIN A-I (APO A-I)?

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 A-I (APO A-I)?

The FDA product code for APOLIPOPROTEIN A-I (APO A-I) is DEL.

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Other records listing Sigma Chemical Co. as applicant

K933694SIGMA GLUCOSE REAGENT K933678SIGMA CALCIUM REAGENT K933696SIGMA ELECTROLYTE REFERENCE REAGENT K933691SIGMA CO2 ALKALINE BUFFER REAGENT K933679SIGMA BUN REAGENT K933703SIGMA WASH CONCENTRATE SOLUTION

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Related Devices (Code: DEL)

K013278TINA-QUANT APOLIPOPROTEIN A-1 VER.2Roche Diagnostics Corp.K900124APOLIPOPROTEIN B (APO B)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.