GKJ — Spinner, Slide, Automated Class I
FDA product code GKJ covers "Spinner, Slide, Automated", a Class I medical device regulated under 21 CFR 864.5850. Submissions are reviewed by the Hematology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- GKJ
- Device Class
- Class I
- Regulation Number
- 864.5850
- Submission Type
- Review Panel
- HE
- Medical Specialty
- Hematology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K854962 | Ulster Scientific | MICRO-MAT SYSTEM | Dec 23, 1985 |
| K854121 | Prevo Micro-Mat System | MICRO-MAT SYSTEM | Oct 31, 1985 |
| K831558 | Coulter Electronics | E-Z PREP | Jun 16, 1983 |
| K811534 | Geometric Data, Div. Smithkline | HEMASPINNER | Aug 18, 1981 |
| K771898 | Dynatech Cryomedical | AUTOMATED SLIDE SPINNER | Oct 18, 1977 |
| K760007 | Geometric Data, Div. Smithkline | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | Sep 3, 1976 |