510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K982062Substantially Equivalent

Cryo-Check Pnp Platelet Lysate, Model Pnp-10

Precision Biologicals, Inc., Dartmouth, Nova Scotia, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K982062 is the FDA 510(k) clearance record for CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10, a class II device, cleared for Precision Biologicals, Inc. on under FDA product code GGW (Test, Time, Partial Thromboplastin). FDA records list 20 510(k) clearances for Precision Biologicals, Inc., from to . As of , FDA records show no recalls naming K982062.

Clearance record

Decision date
Received
(212 days to decision)
Product code
GGW Test, Time, Partial Thromboplastin
Regulation
21 CFR 864.7925
Device class
Class II
Review panel
Hematology
Applicant
Precision Biologicals, Inc. 900 Windmill Rd., Dartmouth, Nova Scotia, 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