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 | December 23, 1985 |
| K854121 | prevo micro-mat system | MICRO-MAT SYSTEM | October 31, 1985 |
| K831558 | coulter electronics | E-Z PREP | June 16, 1983 |
| K811534 | geometric data, div. smithkline | HEMASPINNER | August 18, 1981 |
| K771898 | dynatech cryomedical | AUTOMATED SLIDE SPINNER | October 18, 1977 |
| K760007 | geometric data, div. smithkline | BLOOD-SMEARING INSTRUMENT (MINIPREP TM) | September 3, 1976 |