FDA Product Code
FDA Product Code GKJ — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Hematology
- 21 CFR Citation
- 864.5850
510(k) Clearances — 6 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K854962 | MICRO-MAT SYSTEM | Ulster Scientific, Inc. | 1985-12-23 | Traditional | PDF ↗ |
| K854121 | MICRO-MAT SYSTEM | Prevo Micro-Mat System | 1985-10-31 | Traditional | PDF ↗ |
| K831558 | E-Z PREP | Coulter Electronics, Inc. | 1983-06-16 | Traditional | PDF ↗ |
| K811534 | HEMASPINNER | Geometric Data, Div. Smithkline Corp. | 1981-08-18 | Traditional | PDF ↗ |
| K771898 | AUTOMATED SLIDE SPINNER | Dynatech Cryomedical Co. | 1977-10-18 | Traditional | PDF ↗ |
| K760007 | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Geometric Data, Div. Smithkline Corp. | 1976-09-03 | Traditional | PDF ↗ |
Product code GKJ · Class I · Hematology. Data: openFDA.