Predictor
510(k) K780240
Predictor is a Class II device made by Organon, Inc., cleared under FDA 510(k) K780240 on 27 Feb 1978, 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 | NumberK780240 | Date27 Feb 1978 | StatusActive |
Official records
- FDA 510(k) database K780240
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LCX
- Device class
- Class II
- Regulation
- 21 CFR Part 862.1155
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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