Single (Specified) Analyte Control (Assayed)
510(k) K894804
Single (Specified) Analyte Control (Assayed) is a Class I device made by Lifescan, Inc., cleared under FDA 510(k) K894804 on 28 Sep 1989, 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 | NumberK894804 | Date28 Sep 1989 | StatusActive |
Official records
- FDA 510(k) database K894804
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- Withdrawn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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