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Precision Biologicals, Inc.

FDA 510(k) & PMA Approved Devices — 20 products

Total Devices20
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) K982062 CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10GGW1999-01-13 View
510(k) K981173 CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)GJT1999-01-13 View
510(k) K981174 CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)GJT1999-01-13 View
510(k) K971219 CRYO CHECK INR VALIDATION SETGGN1997-08-29 View
510(k) K971222 CRYO CHECK APC RESISTANT PLASMAGGN1997-08-19 View
510(k) K971223 CRYO CHECK FACTOR V DEFICIENT PLASMAGJT1997-07-22 View
510(k) K971227 CRYO CHECK FACTOR X DEFICIENT PLASMAGJT1997-07-18 View
510(k) K971226 CRYO CHECK FACTOR IX DEFICIENT PLASMAGJT1997-07-18 View
510(k) K971225 CRYO CHECK FACTOR VIII DEFICIENT PLASMAGJT1997-07-17 View
510(k) K971224 CRYO CHECK FACTOR VII DEFICIENT PLASMAGJT1997-07-17 View
510(k) K951823 CRYO CHECK LOW FIBRINOGEN CONTROLGGN1996-01-03 View
510(k) K952623 CRYO CHECK LUPUS PLASMAGGC1995-11-06 View
510(k) K952624 CRYO CHECK ABNORMAL REFERENCE CHECK I & IIGGC1995-10-30 View
510(k) K952622 CRYO CHECK NORMAL HUMAN REFERENCE PLASMAGGN1995-10-30 View
510(k) K922887 CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEMGGN1993-02-25 View
510(k) K885244 SAF FECAL COLLECTION KITJSM1989-03-21 View
510(k) K885245 CARY-BLAIR TRANSPORT SYSTEMJSM1989-03-21 View
510(k) K884854 COAGULATION CONTROL PLASMA (NORMAL & ABNORMAL)GGN1989-01-30 View
510(k) K884856 APTT REAGENTGFO1989-01-30 View
510(k) K884855 THROMBOPLASTINGJS1989-01-30 View
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