510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K012755Substantially Equivalent

Autodimer Assay Model # 1431

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

K012755 is the FDA 510(k) clearance record for AUTODIMER ASSAY MODEL # 1431, a class II device, cleared for Xtrana, Inc. on under FDA product code DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control). FDA records list one 510(k) clearance for Xtrana, Inc. As of , FDA records show no recalls naming K012755.

Clearance record

Decision date
Received
(211 days to decision)
Product code
DAP Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control
Regulation
21 CFR 864.7320
Device class
Class II
Review panel
Hematology
Applicant
Xtrana, Inc. 6025 Nicolle St., Ventura CA
510(k) summary
Statement
Third party review
No

Clearances, product code DAP

Trailing 12 months
1 clearance under product code DAP in the twelve months to October 2026, August 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DAP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260