Pacific Hemostasis
Huntersville, NC, US
Pacific Hemostasis appears in FDA device records in Huntersville, NC. FDA records list 29 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 29
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 29 510(k) clearances for Pacific Hemostasis between 1978 and 2000. The busiest year on record is 1999, with 5. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1979 | 2 |
| 1980 | 3 |
| 1981 | 3 |
| 1982 | 1 |
| 1984 | 1 |
| 1985 | 2 |
| 1987 | 2 |
| 1989 | 1 |
| 1995 | 1 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 5 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K000679 | THROMBOSTRATE CONTROL PLASMAS | GGN | Substantially Equivalent | |
| K994100 | PACIFIC HEMOSTASIS THROMBOPLASTIN D | GJS | Substantially Equivalent | |
| K992130 | PACIFIC HEMOSTASIS THROMBOSCREEN 400C | KQG | Substantially Equivalent | |
| K992279 | HEPARIN CONTROL PLASMA LEVEL 2 | GGN | Substantially Equivalent | |
| K992278 | HEPARIN CONTROL PLASMA LEVEL 1 | GGN | Substantially Equivalent | |
| K991321 | PACIFIC HEMOSTASIS THROMBOSCREEN 200 | KQG | Substantially Equivalent | |
| K990046 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA | GJT | Substantially Equivalent | |
| K984131 | COAGULATION CONTROL LEVEL 3 (ABNORMAL) | GGC | Substantially Equivalent | |
| K984130 | COAGULATION CONTROL LEVEL 2 (ABNORMAL) | GGC | Substantially Equivalent | |
| K984129 | COAGULATION CONTROL LEVEL 1 (NORMAL) | GIZ | Substantially Equivalent | |
| K972627 | PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056) | GJT | Substantially Equivalent | |
| K971428 | COAGULATION CONTROL PLASMA(ABNORMAL)LEVEL 0 | GGN | Substantially Equivalent | |
| K940082 | THROMBOSCREEN THROMBOPLASTIN-DS | GJS | Substantially Equivalent | |
| K891337 | THROMBOSCREEN APTT REAGENT | GFO | Substantially Equivalent | |
| K872217 | THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT | GHM | Substantially Equivalent | |
| K864643 | GLYCOSCREEN GLYCOSYLATED HEMOGLOBIN ASSAY KIT | LCP | Substantially Equivalent | |
| K854079 | THROMBO SCREEN SICKLE CELL ASSAY SET | GHM | Substantially Equivalent | |
| K852512 | THROMBO SCREEEN FIBRIN DEGRADATION PRODUCT KIT | GHH | Substantially Equivalent | |
| K834086 | CONTACT-K APTT REAGENT | GGN | Substantially Equivalent | |
| K820450 | THROMBOSCREEN | GIT | Substantially Equivalent | |
| K812658 | CEA CONTROL PLASMA | DHX | Substantially Equivalent | |
| K812215 | ANTITHROMBIN III SCREEN KIT | JBQ | Substantially Equivalent | |
| K810350 | THROMBOPLASTIN | GJS | Substantially Equivalent | |
| K801460 | PACIFIC HEMOSTASIS THROMBO-SCREEN KAPTT | GGW | Substantially Equivalent | |
| K800826 | FIBRINOGEN SCREEN | KQJ | Substantially Equivalent | |
| K800146 | PLATELET AGGREGATION REAGENTS | JOZ | Substantially Equivalent | |
| K791022 | PROTHROMBIN REFERENCE PLASMA (HUMAN) | GJS | Substantially Equivalent | |
| K791023 | PROTHROMBIN FREE BEEF PLASMA (PFB) | GJS | Substantially Equivalent | |
| K781880 | ASSAY KIT, THROMBO-SCREEN | GIS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GFOActivated Partial Thromboplastin
- JBQAntithrombin Iii Quantitation
- LCPAssay, Glycosylated Hemoglobin
- GGCControl, Plasma, Abnormal
- GHHFibrin Split Products
- KQGInstrument, Coagulation
- GGNPlasma, Coagulation Control
- GJTPlasma, Coagulation Factor Deficient
- GIZPlasma, Control, Normal
- GITReagent & Control, Partial Thromboplastin Time
- JOZSystem, Automated Platelet Aggregation
- KQJSystem, Fibrinogen Determination
- DHXSystem, Test, Carcinoembryonic Antigen
- GISTest, Fibrinogen
- GHMTest, Sickle Cell
- GGWTest, Time, Partial Thromboplastin
- GJSTest, Time, Prothrombin
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain