FDA.reportPublic FDA data

Precision BioLogic Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
80435993005917516Precision BioLogic Inc.1N2027-01-01140 Eileen Stubbs Avenue Dartmouth Nova Scotia CA B3B 0A9

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
760821947097978K990814CRYO CHECK FACTOR 2 DEFICIENT PLASMA, MODELS FDPO2-10, FDP02-15GJT1999-06-07
760821344771753K990580CRYOCHECK LA SURE, MODEL SUR25-10GIR1999-07-28
760821265142362K990579CRYOCHECK LA CHECK, MODELS CHK25-10 (25 X1.0 ML), CHK80-10 (80 X 1.0 ML)GIR1999-07-23
760821174938966K990296CRYOCHECK PREKALLIKREIN DEFICIENT PLALSMA, MODEL FDPK10/10 (10 X 1.0 ML), FDPK10/25 (25 X 1.0ML)GJT1999-03-18
760821708243038K982062CRYO-CHECK PNP PLATELET LYSATE, MODEL PNP-10GGW1999-01-13
760821861904300K981174CRYO CHECK FACTOR XII DEFICIENT PLASMA MODEL FDP12-10 (1.0ML) AND FDP12-15 (1.5ML)GJT1999-01-13
760821285976595K981173CRYO CHECK FACTOR XI DEFICIENT PLASMA, MODEL FDP11-10 (1.OML) AND FDP11-15 (1.5ML)GJT1999-01-13
760821372036344K971227CRYO CHECK FACTOR X DEFICIENT PLASMAGJT1997-07-18
760821115525074K971226CRYO CHECK FACTOR IX DEFICIENT PLASMAGJT1997-07-18
760821135052385K971225CRYO CHECK FACTOR VIII DEFICIENT PLASMAGJT1997-07-17
760821220154024K971224CRYO CHECK FACTOR VII DEFICIENT PLASMAGJT1997-07-17
760821364522198K971223CRYO CHECK FACTOR V DEFICIENT PLASMAGJT1997-07-22
760821535803369K971222CRYO CHECK APC RESISTANT PLASMAGGN1997-08-19
760822056809333K952624CRYO CHECK ABNORMAL REFERENCE CHECK I & IIGGC1995-10-30
760821578431230K952623CRYO CHECK LUPUS PLASMAGGC1995-11-06
760821874871763K952622CRYO CHECK NORMAL HUMAN REFERENCE PLASMAGGN1995-10-30
760821792403192K951823CRYO CHECK LOW FIBRINOGEN CONTROLGGN1996-01-03
760821270840522K922887CRYP CHECK IN-VITRO COAGULATION CONTROL SYSTEMGGN1993-02-25
760821998133336K251440CRYOcheck Chromogenic Factor VIIIGGP2025-08-25
760821488459791K222831CRYOcheck Factor VIII Deficient Plasma with VWFGJT2023-09-13
760822009107671K214002CRYOcheck Chromogenic Factor IXGGP2022-12-23
760822055521734K193556Cryocheck Hex LAGFO2020-10-23
760821988956256K193204Cryocheck Chromogenic Factor VIIIGGP2020-07-17
760821485945746K183440CRYOcheck FVIII Inhibitor KitGGP2019-03-12
760821279383759K043571CRYOCHECK CLOT SGGP2005-03-18
760821613420461K040987CRYOCHECK CLOT CGGP2004-06-18
760821307468912K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLGGC2003-11-03
760821280221800K013708REFERENCE CHECK, CATALOG NUMBER-RCN-10GIZ2001-12-10
760821469840516

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GJT102023-09-13
GGP62025-08-25
GGN41997-08-19
GGC32003-11-03
GIR21999-07-28
GFO12020-10-23
GIZ12001-12-10
GGW11999-01-13

PMN#