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510(k) K100727
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK100727 | Date14 Sep 2010 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JJY
- Device Class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent