FDA Product Code
FDA Product Code GIL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.7340
510(k) Clearances — 8 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K962407 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | 1996-07-29 | Traditional | PDF ↗ |
| K946193 | FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 | More Diagnostics | 1995-08-24 | Traditional | PDF ↗ |
| K946265 | FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 | Clinical Controls, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K935598 | PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 | Clinical Controls, Inc. | 1995-05-02 | Traditional | PDF ↗ |
| K951012 | N/T PROTEIN CONTROL PY | Behring Diagnostics, Inc. | 1995-04-17 | Traditional | PDF ↗ |
| K934741 | LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2 | Clinical Controls, Inc. | 1994-09-08 | Traditional | PDF ↗ |
| K915462 | FIBRINOGEN CONTROL | Sigma Diagnostics, Inc. | 1992-03-04 | Traditional | PDF ↗ |
| K833352 | GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL | Warner-Lambert Co. | 1983-11-03 | Traditional | PDF ↗ |
Product code GIL · Class II · Hematology. Data: openFDA.