FDA Product Code
FDA Product Code GJS — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7750
510(k) Clearances — 127 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K883441 | VISION(R) PROTHROMBIN TIME | Abbott Laboratories | 1988-09-13 | Traditional | PDF ↗ |
| K882456 | COAG-I PT TEST CARD | Cardiovascular Diagnostic Services | 1988-08-25 | Traditional | PDF ↗ |
| K882214 | SIMPLASTIN EXCEL S | Organon Teknika Corp. | 1988-07-01 | Traditional | PDF ↗ |
| K880566 | CLP PROTHROMBIN TIME TEST | Creative Laboratory Products, Inc. | 1988-03-23 | Traditional | PDF ↗ |
| K875062 | EASY-TEST PROTHROMBIN TIME PT ITEM NO. 16628 | Em Diagnostic Systems, Inc. | 1988-02-11 | Traditional | PDF ↗ |
| K874592 | THROMBOPLASTIN.C | Baxter Healthcare Corp | 1988-02-04 | Traditional | PDF ↗ |
| K872537 | PROTHROMBIN TIME TEST | Sclavo, Inc. | 1987-08-27 | Traditional | PDF ↗ |
| K872844 | THROMBOREL S | Behring Diagnostics, Inc. | 1987-08-06 | Traditional | PDF ↗ |
| K870596 | PROTHROMBIN TIME TEST | U. S. Diagnostics, Inc. | 1987-04-20 | Traditional | PDF ↗ |
| K864392 | PROTIME AUTOMATE TEST KIT | American Bioproducts Co. | 1987-01-05 | Traditional | PDF ↗ |
| K864283 | SIMPLASTIN EXCEL | Organon Teknika Corp. | 1986-12-04 | Traditional | PDF ↗ |
| K864272 | THROMBOPLASTIN.FS | American Dade | 1986-11-13 | Traditional | PDF ↗ |
| K864274 | THROMBOPLASTIN.R | American Dade | 1986-11-13 | Traditional | PDF ↗ |
| K864273 | THROMBOPLASTIN.C | American Dade | 1986-11-13 | Traditional | PDF ↗ |
| K860721 | BIOTRACK PROTIME TEST PROTHROMBIN TIME TEST | Biotrack, Inc. | 1986-05-23 | Traditional | PDF ↗ |
| K852484 | PLASTINEX | Bio/Data Corp. | 1985-08-12 | Traditional | PDF ↗ |
| K851125 | ACA PROTHROMBIN TIME ANALYTICAL TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1985-05-29 | Traditional | PDF ↗ |
| K843535 | ORTHO BRAIN THROMBOPLASTIN DILUENT | Ortho Diagnostic Systems, Inc. | 1984-12-12 | Traditional | PDF ↗ |
| K840802 | DIA THROMBIN DIA PLASTIN | Diatech, Inc. | 1984-05-01 | Traditional | PDF ↗ |
| K832427 | EASYTOUCH TROMBOPLASTIN REAGENT | Worthington Diagnostic Systems | 1983-10-14 | Traditional | PDF ↗ |
| K830331 | LIQUID THROMBOPLASTIN REAGENT | Helena Laboratories | 1983-04-05 | Traditional | PDF ↗ |
| K811784 | SIGMA PROCEDURE #890 | Sigma Chemical Co. | 1981-07-27 | Traditional | PDF ↗ |
| K810350 | THROMBOPLASTIN | Pacific Hemostasis | 1981-04-14 | Traditional | PDF ↗ |
| K792031 | LANCER COAGENT PT KIT | Sherwood Medical Co. | 1979-11-05 | Traditional | PDF ↗ |
| K791022 | PROTHROMBIN REFERENCE PLASMA (HUMAN) | Pacific Hemostasis | 1979-07-24 | Traditional | PDF ↗ |
| K791023 | PROTHROMBIN FREE BEEF PLASMA (PFB) | Pacific Hemostasis | 1979-06-28 | Traditional | PDF ↗ |
| K780203 | THROMBOPLASTIN DRIED | Hyland Therapeutic Div., Travenol Laboratories | 1978-03-27 | Traditional | PDF ↗ |
Product code GJS · Class II · Hematology. Data: openFDA.