JST — Kit, Fastidious Organisms Class I
FDA product code JST covers "Kit, Fastidious Organisms", a Class I medical device regulated under 21 CFR 866.2660. Submissions are reviewed by the Microbiology panel. At least 6 recent 510(k) clearances have been granted under this product code.
Classification details
- Product Code
- JST
- Device Class
- Class I
- Regulation Number
- 866.2660
- Submission Type
- 510(k) Exempt
- Review Panel
- MI
- Medical Specialty
- Microbiology
- Implant
- No
Recent 510(k) clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K962423 | Becton Dickinson Microbiology Systems | BBLCRYSTAL NEISSERIA/HAEMOPHILUS (N/H) SYSTEM | Aug 2, 1996 |
| K854732 | Dms Products | API 50 CHB (CULTURE MEDIA) | Mar 4, 1986 |
| K841661 | Oxoid U.S.A | SYNTHETIC BROTH A.O.A.C. | May 11, 1984 |
| K832051 | Austin Biological Laboratories | RIM-HAEMOPHILUS 1 & 2 | Aug 12, 1983 |
| K832239 | Austin Biological Laboratories | RIM-HAEMOPHILUS 2 | Aug 12, 1983 |
| K831349 | Granite Diagnostics | STREPTOCOCUS ID PLATE | May 16, 1983 |