JTSClass I
Stains, Microbiologic
21 CFR 864.1850 / Hematology
JTS is the FDA product code for Stains, Microbiologic, a class I device type, regulated under 21 CFR 864.1850. As of , FDA records hold 40 510(k) clearances under this code, the most recent dated , and 9 recalls.
Classification record
- Product code
- JTS
- Device name
- Stains, Microbiologic
- Regulation
- 21 CFR 864.1850
- Device class
- Class I
- Review panel
- Hematology
- Submission type
- 510(k) exempt
- Implant
- No
- Life sustaining or supporting
- No
- GMP exempt
- Yes
- Third party review eligible
- No
- Ingested clearances
- 40
- Ingested recalls
- 9
Clearances, product code JTS
By decision yearShow the numbers
| Year | Clearances |
|---|---|
| 1978 | 3 |
| 1981 | 3 |
| 1982 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| 1985 | 3 |
| 1987 | 10 |
| 1988 | 9 |
| 1989 | 3 |
| 1992 | 3 |
| 1996 | 2 |
Applicants with the most clearances
Product code JTS| Applicant | Clearances |
|---|---|
| Remel Inc | 12 |
| Alpha-Tec Systems, Inc. | 5 |
| Accra Laboratories, Inc. | 4 |
| Scientific Device Laboratory, Inc. | 3 |
| Marion Laboratories, Inc. | 2 |
| Alpha-Tech Systems, Inc. | 1 |
| American Micro Scan | 1 |
| BD Becton Dickinson Vacutainer Systems Preanalytic | 1 |
| Bioscientific | 1 |
| Carr-Scarborough Microbiologicals, Inc. | 1 |
Companies listing this code with FDA
Companies whose registered establishments list this codeFIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.