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510(k) K981173

CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML) by Precision Biologicals, Inc. — Product Code GJT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1999
Date Received
April 1, 1998
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 Biologicals, Inc.

  • K981174 — CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5M (January 13, 1999)
  • K982062 — CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10 (January 13, 1999)
  • K971219 — CRYO CHECK INR VALIDATION SET (August 29, 1997)
  • K971222 — CRYO CHECK APC RESISTANT PLASMA (August 19, 1997)
  • K971223 — CRYO CHECK FACTOR V DEFICIENT PLASMA (July 22, 1997)
  • K971226 — CRYO CHECK FACTOR IX DEFICIENT PLASMA (July 18, 1997)
  • K971227 — CRYO CHECK FACTOR X DEFICIENT PLASMA (July 18, 1997)
  • K971224 — CRYO CHECK FACTOR VII DEFICIENT PLASMA (July 17, 1997)
  • K971225 — CRYO CHECK FACTOR VIII DEFICIENT PLASMA (July 17, 1997)
  • K951823 — CRYO CHECK LOW FIBRINOGEN CONTROL (January 3, 1996)

Other clearances for product code GJT

  • K222831 — CRYOcheck Factor VIII Deficient Plasma with VWF (September 13, 2023)
  • K180486 — HemosIL Factor XII Deficient Plasma (March 22, 2018)
  • K102851 — NOFACT VIII (December 19, 2011)
  • K102908 — NOFACT IX (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)