Company ยท US
Pacific Hemostasis
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2000. Name variants (Inc, Corp, punctuation) are merged.
29510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| GGN | Plasma, Coagulation Control | 5 |
| GJS | Test, Time, Prothrombin | 5 |
| GGC | Control, Plasma, Abnormal | 2 |
| GHM | Test, Sickle Cell | 2 |
| GJT | Plasma, Coagulation Factor Deficient | 2 |
| KQG | Instrument, Coagulation | 2 |
| DHX | System, Test, Carcinoembryonic Antigen | 1 |
| GFO | Activated Partial Thromboplastin | 1 |
| GGW | Test, Time, Partial Thromboplastin | 1 |
| GHH | Fibrin Split Products | 1 |
| GIS | Test, Fibrinogen | 1 |
| GIT | Reagent & Control, Partial Thromboplastin Time | 1 |
| GIZ | Plasma, Control, Normal | 1 |
| JBQ | Antithrombin Iii Quantitation | 1 |
| JOZ | System, Automated Platelet Aggregation | 1 |
| KQJ | System, Fibrinogen Determination | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 24, 2000 | K000679 | THROMBOSTRATE CONTROL PLASMAS Pacific Hemostasis | GGN |
| Feb 18, 2000 | K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D Pacific Hemostasis | GJS |
| Sep 3, 1999 | K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C Pacific Hemostasis | KQG |
| Aug 26, 1999 | K992279 | HEPARIN CONTROL PLASMA LEVEL 2 Pacific Hemostasis | GGN |
| Aug 26, 1999 | K992278 | HEPARIN CONTROL PLASMA LEVEL 1 Pacific Hemostasis | GGN |
| Jun 21, 1999 | K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 Pacific Hemostasis | KQG |
| Feb 17, 1999 | K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA Pacific Hemostasis | GJT |
| Dec 1, 1998 | K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) Pacific Hemostasis | GGC |
| Dec 1, 1998 | K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) Pacific Hemostasis | GGC |
| Dec 1, 1998 | K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) Pacific Hemostasis | GIZ |
| Aug 13, 1997 | K972627 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) Pacific Hemostasis | GJT |
| Jun 17, 1997 | K971428 | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 Pacific Hemostasis | GGN |
| Feb 14, 1995 | K940082 | THROMBOSCREEN THROMBOPLASTIN-DS Pacific Hemostasis | GJS |
| Apr 21, 1989 | K891337 | THROMBOSCREEN APTT REAGENT Pacific Hemostasis | GFO |
| Jul 31, 1987 | K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT Pacific Hemostasis | GHM |
| Apr 28, 1987 | K864643 | GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT Pacific Hemostasis | LCP |
| Oct 31, 1985 | K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET Pacific Hemostasis | GHM |
| Sep 17, 1985 | K852512 | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT Pacific Hemostasis | GHH |
| Feb 3, 1984 | K834086 | CONTACT-K APTT REAGENT Pacific Hemostasis | GGN |
| Mar 26, 1982 | K820450 | THROMBOSCREEN Pacific Hemostasis | GIT |
| Sep 29, 1981 | K812658 | CEA CONTROL PLASMA Pacific Hemostasis | DHX |
| Sep 1, 1981 | K812215 | ANTITHROMBIN III SCREEN KIT Pacific Hemostasis | JBQ |
| Apr 14, 1981 | K810350 | THROMBOPLASTIN Pacific Hemostasis | GJS |
| Jul 28, 1980 | K801460 | PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT Pacific Hemostasis | GGW |
| May 30, 1980 | K800826 | FIBRINOGEN SCREEN Pacific Hemostasis | KQJ |
| Feb 5, 1980 | K800146 | PLATELET AGGREGATION REAGENTS Pacific Hemostasis | JOZ |
| Jul 24, 1979 | K791022 | PROTHROMBIN REFERENCE PLASMA (HUMAN) Pacific Hemostasis | GJS |
| Jun 28, 1979 | K791023 | PROTHROMBIN FREE BEEF PLASMA (PFB) Pacific Hemostasis | GJS |
| Dec 4, 1978 | K781880 | ASSAY KIT, THROMBO-SCREEN Pacific Hemostasis | GIS |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||