Panels › Hematology › Product code GGP · Class 2
Test, Qualitative And Quantitative Factor Deficiency
Regulation 864.7290
0510(k)s in 12 months (190 all time)
2recalls in 12 months (14 all time)
12recalls that name a 510(k)
Top companies in GGP
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 29, 1985 | K853462 | COAGULATION FACTOR VIII DEFICIENT SUBSTRATE PLASMA American Dade | GGP |
| Aug 29, 1985 | K853461 | COAGULATION FACTOR IX DEFICIENT SUBSTRATE PLASMA American Dade | GGP |
| Nov 19, 1984 | K843451 | FACTOR XII DEFICIENT PLASMA B12D Sigma Chemical Co. | GGP |
| Nov 19, 1984 | K843438 | FACTOR XI DEFICIENT PLASMA B11D Sigma Chemical Co. | GGP |
| Nov 19, 1984 | K843310 | FACTOR X DEFICIENT PLASMA, BLOD HUMAN Sigma Chemical Co. | GGP |
| Nov 19, 1984 | K843215 | FACTOR IX DEFICIENT PLASMA, B9D - Sigma Chemical Co. | GGP |
| Oct 1, 1984 | K842617 | VONWILLEBRAND FACTOR ANTIGEN SEMI-QUANT American Dade | GGP |
| Jul 19, 1984 | K841957 | BOVINE FACTOR XA-HUMAN FACTOR XA Haemachem, Inc. | GGP |
| Jul 19, 1984 | K841708 | MELOY IMMUNOSTAT MONOCLONAL FACTOR VIII Meloy Laboratories, Inc. | GGP |
| May 2, 1984 | K841461 | COAGULATION CONTROL PLASMA LEVEL 1/2/3 Diatech, Inc. | GGP |
| Apr 30, 1984 | K840928 | FACTOR DEFICIENT SUBSTRATE PLASMA VIII Diatech, Inc. | GGP |
| Apr 30, 1984 | K840927 | FACTOR DEFICIENT SUBSTRATE PLASMA II Diatech, Inc. | GGP |
| Apr 25, 1984 | K841364 | COAGULATION FACTOR V DEFICIENT SUBSTR American Dade | GGP |
| Apr 5, 1984 | K840329 | RISTOCETIN COFACTOR ASSAY Helena Laboratories | GGP |
| Feb 4, 1984 | K840114 | COAGULATION FACTOR DEFICIENT PLASMA Medical Specialties Laboratories | GGP |
| Feb 4, 1984 | K834051 | PROTOPATH FACTOR VIII ASSAY American Dade | GGP |
| Feb 4, 1984 | K834050 | PROTOPATH FACTOR IX ASSAY American Dade | GGP |
| Jan 30, 1984 | K833892 | COATEST FACTOR VIII Kabivitrum, Inc. | GGP |
| Dec 16, 1983 | K834031 | FACTOR II DEFICIENT SUBSTRATE PLASMA Helena Laboratories | GGP |
| Sep 29, 1983 | K832372 | DIACROM * FACTOR X KIT HA31 Wellcome Diagnostics | GGP |
| Aug 26, 1983 | K832114 | COATEST FACTOR X Kabivitrum, Inc. | GGP |
| Jan 21, 1983 | K823453 | VON WILLEBRAND FACTOR ASSAY General Diagnostics | GGP |
| Dec 28, 1982 | K823267 | FACTOR VIII RELATED ANTIGEN ROCKET EID Helena Laboratories | GGP |
| Jul 27, 1982 | K821963 | EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT. Intl. Immunoassay Laboratories, Inc. | GGP |
| Feb 23, 1982 | K820085 | DADE FACTOR ASSAY REFERENCE PLASMA American Dade | GGP |
| Nov 16, 1981 | K812975 | LANCER COAGENT HUMAN VACTOR VIII PLASMA Sherwood Medical Co. | GGP |
| Nov 16, 1981 | K812974 | LANCER COAGENT HUMAN FACTOR 1X PLASMA Sherwood Medical Co. | GGP |
| Sep 23, 1981 | K812431 | FACTOR VIII DEFICIENT PLASMA #B8D Sigma Chemical Co. | GGP |
| Dec 1, 1980 | K802356 | VON WILLEBRAND FACTOR ASSAY Bio/Data Corp. | GGP |
| Jan 24, 1980 | K792656 | HELENA FACTOR XII DEFICIENT Helena Laboratories | GGP |
| Dec 31, 1979 | K792511 | HELENA FACTOR VII DEFICIENT SUB. PLASMA Helena Laboratories | GGP |
| Dec 31, 1979 | K792508 | HELENA FACTOR X DEFICIENT SUBSTRATE Helena Laboratories | GGP |
| Dec 31, 1979 | K792507 | HELENA FACTOR V DEFICIENT SUBSTRATE Helena Laboratories | GGP |
| Dec 31, 1979 | K792476 | HELENA FACTOR XI DEFICIENT SUBSTRATE Helena Laboratories | GGP |
| Dec 31, 1979 | K792475 | HELENA FACTOR IX DEFICIENT SUBSTRATE Helena Laboratories | GGP |
| Dec 27, 1979 | K792336 | HELENA FACTOR II DEFICIENT SUB. PLASMA Helena Laboratories | GGP |
| Dec 4, 1979 | K792335 | HELENA FACTOR VIII DEFICIENT SUB. PLASMA Helena Laboratories | GGP |
| Oct 1, 1979 | K791794 | FACTOR VII DEFICIENT PLASMA Sigma Chemical Co. | GGP |
| Apr 4, 1979 | K790423 | FACTOR V DEFICIENT Sigma Chemical Co. | GGP |
| Feb 7, 1977 | K761058 | QUAN-8 MULT-COMP FACTOR VIII ASSAY KIT Bio/Data Corp. | GGP |
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