510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K090413Substantially Equivalent

A1cnow+ (10 Test Kit, Professional Use) Model 3024, A1cnow+(20 Test Kit, Professional Use) Model 3021, A1cnow Self Chec

Medrad, Inc., Sunnyvale CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090413 is the FDA 510(k) clearance record for A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC, a class II device, cleared for Bayer Healthcare, LLC on under FDA product code LCP (Assay, Glycosylated Hemoglobin). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show 7 recalls naming K090413.

Clearance record

Decision date
Received
(85 days to decision)
Product code
LCP Assay, Glycosylated Hemoglobin
Regulation
21 CFR 864.7470
Device class
Class II
Review panel
Hematology
Applicant
Bayer Healthcare, LLC 510 Oakmead Pkwy., Sunnyvale CA
510(k) summary
Summary PDF
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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LCP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260