DUOCLON SLIDE TEST
FDA 510(k) clearance K831109 · decided 1983-06-02
Clearance details
- K-number
- K831109
- Device name
- DUOCLON SLIDE TEST
- Applicant
- Organon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-04-05
- Decision date
- 1983-06-02
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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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 |