510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023362Substantially Equivalent

Fisher Diagnostics Thromboscreen 1000; Pacific Hemostasis Fibrinogen Reagent Plus Kaolin

Fisher Diagnostics, Middletown VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023362 is the FDA 510(k) clearance record for FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FIBRINOGEN REAGENT PLUS KAOLIN, a class II device, cleared for Fisher Diagnostics on under FDA product code GKP (Instrument, Coagulation, Automated). FDA records list 16 510(k) clearances for Fisher Diagnostics, from to . As of , FDA records show no recalls naming K023362.

Clearance record

Decision date
Received
(63 days to decision)
Product code
GKP Instrument, Coagulation, Automated
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Fisher Diagnostics 8365 Valley Pike, Middletown VA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GKP

Trailing 12 months

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

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