El-B2GP1SCR
by Theratest Laboratories, Inc.
510(k) K973882
El-B2GP1SCR is a Class II device made by Theratest Laboratories, Inc., cleared under FDA 510(k) K973882 on 5 Dec 1997, active as of 9 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK973882 | Date5 Dec 1997 | StatusActive |
Official records
- FDA 510(k) database K973882
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- MSV
- Device class
- Class II
- Regulation
- 21 CFR Part 866.5660
- Advisory committee
- Immunology
- FDA decision
- SESE Substantially Equivalent
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