PREDICTOR
FDA 510(k) clearance K780240 · decided 1978-02-27
Clearance details
- K-number
- K780240
- Device name
- PREDICTOR
- Applicant
- Organon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-13
- Decision date
- 1978-02-27
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- LCX
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| GONOSTICON DRI-DOT TEST (N17985/S002) | Organon, Inc. | 1983-01-04 |
| GONOSTICON DRI-DOT (N17985/S001) | Organon, Inc. | 1981-04-14 |