Streptococus Id Plate
by Granite Diagnostics, Inc. 510(k)
Active
510(k) K831349
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK831349 | Date16 May 1983 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 11 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JST
- Device Class
- Class I
- Regulation
- 21 CFR Part 866.2660
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent