510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K060284Substantially Equivalent

Cryocheck Clot Apcr

Precision BioLogic Inc., Dartmouth, N.S., CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K060284 is the FDA 510(k) clearance record for CRYOCHECK CLOT APCR, a class II device, cleared for Precision Biologic, Inc. on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list 17 510(k) clearances for Precision Biologic, Inc., from to . As of , FDA records show no recalls naming K060284.

Clearance record

Decision date
Received
(96 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Precision Biologic, Inc. 900 Windmill Rd., Suite 100, Dartmouth, N.S., CA
510(k) summary
Summary PDF
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