510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854572Substantially Equivalent

Coatest Plasminogen

Kabivitrum, Inc., Alameda CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854572 is the FDA 510(k) clearance record for COATEST PLASMINOGEN, a class I device, cleared for Kabivitrum, Inc. on under FDA product code DDX (Plasminogen, Antigen, Antiserum, Control). FDA records list 8 510(k) clearances for Kabivitrum, Inc., from to . As of , FDA records show no recalls naming K854572.

Clearance record

Decision date
Received
(104 days to decision)
Product code
DDX Plasminogen, Antigen, Antiserum, Control
Regulation
21 CFR 866.5715
Device class
Class I
Review panel
Immunology
Applicant
Kabivitrum, Inc. 1311 Harbor Bay Pkwy., Alameda CA
Third party review
No

Clearances, product code DDX

Trailing 12 months

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

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