ANTI-SCHISTOSOMA SPECIES KIT
FDA 510(k) clearance K842660 · decided 1984-10-30
Clearance details
- K-number
- K842660
- Device name
- ANTI-SCHISTOSOMA SPECIES KIT
- Applicant
- Amico Lab, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-07-10
- Decision date
- 1984-10-30
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- GNH
- Device class
- 1
- Regulation number
- 866.3600
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- TN, 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.
| Record | Firm | Date |
|---|---|---|
| AMIZYME-SCHISTOSOMA SPP. TEST KIT (K842527) | Amico Lab, Inc. | 1984-09-05 |
Recalls involving this device
No recalls on record reference this clearance.