510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003747Substantially Equivalent

C1-Inhibitor Microtiter Assay Device

Baxter Healthcare Corporation, Glendale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K003747 is the FDA 510(k) clearance record for C1-INHIBITOR MICROTITER ASSAY DEVICE, a class II device, cleared for Baxter Healthcare Corp on under FDA product code DBA (Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control). FDA records list 570 510(k) clearances for Baxter Healthcare Corp, from to . As of , FDA records show no recalls naming K003747.

Clearance record

Decision date
Received
(105 days to decision)
Product code
DBA Complement C1 Inhibitor (Inactivator), Antigen, Antiserum, Control
Regulation
21 CFR 866.5250
Device class
Class II
Review panel
Immunology
Applicant
Baxter Healthcare Corp 550 N. Brand Blvd., Glendale CA
510(k) summary
Summary
Third party review
No

Clearances, product code DBA

Trailing 12 months

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

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