Level II Control Serum
510(k) K821558
Level II Control Serum is a medical device (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Irvine Scientific, cleared under FDA 510(k) K821558 on 2 Jul 1982, active as of 22 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 | NumberK821558 | Date2 Jul 1982 | StatusActive |
Official records
- FDA 510(k) database K821558
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJX
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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