510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K013708Substantially Equivalent

Reference Check, Catalog Number-Rcn-10

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

K013708 is the FDA 510(k) clearance record for REFERENCE CHECK, CATALOG NUMBER-RCN-10, a class II device, cleared for Precision Biologic on under FDA product code GIZ (Plasma, Control, Normal). FDA records list 17 510(k) clearances for Precision Biologic, from to . As of , FDA records show no recalls naming K013708.

Clearance record

Decision date
Received
(32 days to decision)
Product code
GIZ Plasma, Control, Normal
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Precision Biologic 900 Windmill Rd., Suite 100, Dartmouth, N.S., CA
510(k) summary
Summary
Third party review
No

Clearances, product code GIZ

Trailing 12 months

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

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