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510(k) K222831

CRYOcheck Factor VIII Deficient Plasma with VWF by Precision Biologic, Inc. — Product Code GJT

K222831 is an FDA 510(k) premarket notification submitted by Precision Biologic, Inc. for the device "CRYOcheck Factor VIII Deficient Plasma with VWF". The FDA issued a decision of Substantially Equivalent on September 13, 2023. The device falls under product code GJT (Plasma, Coagulation Factor Deficient), a Class II device regulated under 21 CFR 864.7290. Precision Biologic, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2023
Date Received
September 19, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plasma, Coagulation Factor Deficient
Device Class
Class II
Regulation Number
864.7290
Review Panel
HE
Submission Type

Other clearances by Precision Biologic, Inc.

  • K251440 — CRYOcheck Chromogenic Factor VIII (August 25, 2025)
  • K214002 — CRYOcheck Chromogenic Factor IX (December 23, 2022)
  • K193556 — Cryocheck Hex LA (October 23, 2020)
  • K193204 — Cryocheck Chromogenic Factor VIII (July 17, 2020)
  • K183440 — CRYOcheck FVIII Inhibitor Kit (March 12, 2019)
  • K060284 — CRYOCHECK CLOT APCR (May 10, 2006)
  • K043571 — CRYOCHECK CLOT S (March 18, 2005)
  • K040987 — CRYOCHECK CLOT C (June 18, 2004)
  • K032804 — CRYOCHECK WEAK LUPUS POSITIVE CONTROL (November 3, 2003)
  • K023991 — CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (April 28, 2003)

Other clearances for product code GJT

  • K180486 — HemosIL Factor XII Deficient Plasma (March 22, 2018)
  • K102908 — NOFACT IX (December 19, 2011)
  • K102851 — NOFACT VIII (December 19, 2011)
  • K110237 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (July 8, 2011)
  • K050661 — HEMOSIL FACTOR II DEFICIENT PLASMA (May 2, 2005)
  • K043459 — HEMOSIL FACTOR XII DEFICIENT PLASMA (February 9, 2005)
  • K040362 — DIAPHARMA FACTOR X KIT (July 12, 2004)
  • K034007 — HEMOSIL FACTOR VIII DEFICIENT PLASMA (February 13, 2004)
  • K031829 — HEMOSIL FACTOR IX DEFICIENT PLASMA (July 31, 2003)
  • K031122 — HEMOSIL FACTOR X DEFICIENT PLASMA (May 19, 2003)

FDA data resources