510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
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K914069Substantially Equivalent

Reflab(tm) Brand Syst Pk Liq Reagent, Apolipop a-1

Medical Analysis Systems, Inc., Camarillo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914069 is the FDA 510(k) clearance record for REFLAB(TM) BRAND SYST PK LIQ REAGENT, APOLIPOP A-1, a class I device, cleared for Medical Analysis Systems, Inc. on under FDA product code MSJ (Apolipoproteins). FDA records list 107 510(k) clearances for Medical Analysis Systems, Inc., from to . As of , FDA records show no recalls naming K914069.

Clearance record

Decision date
Received
(21 days to decision)
Product code
MSJ Apolipoproteins
Regulation
21 CFR 862.1475
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Medical Analysis Systems, Inc. Lincoln Technology Park, Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code MSJ

Trailing 12 months

FDA records hold no clearances under product code MSJ in the trailing twelve months.

FDA records show no clearances under product code MSJ in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MSJ, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260