510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945940Substantially Equivalent

Coatest(r) Apc(tm) Resistance

Axis-Shield Doc AS, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K945940 is the FDA 510(k) clearance record for COATEST(R) APC(TM) RESISTANCE, a class II device, cleared for Axis-Shield Doc AS on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list one 510(k) clearance for Axis-Shield Doc AS. As of , FDA records show no recalls naming K945940.

Clearance record

Decision date
Received
(245 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Axis-Shield Doc AS P.O. Box 262069, San Diego CA
510(k) summary
Summary
Third party review
No

Clearances, product code GGW

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