510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K920397Substantially Equivalent

Reflab System Pack Liquid Fructosamine Reagent

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

K920397 is the FDA 510(k) clearance record for REFLAB SYSTEM PACK LIQUID FRUCTOSAMINE REAGENT, a class II device, cleared for Medical Analysis Systems, Inc. on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 107 510(k) clearances for Medical Analysis Systems, Inc., from to . As of , FDA records show no recalls naming K920397.

Clearance record

Decision date
Received
(187 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Medical Analysis Systems, Inc. Lincoln Technology Park, Camarillo CA
510(k) summary
Statement
Third party review
No

Clearances, product code LCP

Trailing 12 months

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

FDA records show no clearances under product code LCP in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCP, 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