510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091284Substantially Equivalent

Visucal-F Frozen Calibrator Plasma and Visucon-F Frozen Normal and Abnormal Control Plasma

Affinity Biologicals Inc., Ancaster, Ontario, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091284 is the FDA 510(k) clearance record for VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA, a class II device, cleared for Affinity Biologicals, Inc. on under FDA product code GGN (Plasma, Coagulation Control). FDA records list 5 510(k) clearances for Affinity Biologicals, Inc., from to . As of , FDA records show no recalls naming K091284.

Clearance record

Decision date
Received
(180 days to decision)
Product code
GGN Plasma, Coagulation Control
Regulation
21 CFR 864.5425
Device class
Class II
Review panel
Hematology
Applicant
Affinity Biologicals, Inc. 1395 Sandhill Dr., Ancaster, Ontario, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGN

Trailing 12 months

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

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