PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
FDA 510(k) clearance K002024 · decided 2000-11-22
Clearance details
- K-number
- K002024
- Device name
- PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
- Applicant
- Panbio, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-03
- Decision date
- 2000-11-22
- Days to decision
- 142 days
- Clearance type
- Traditional
- Product code
- GRY
- Device class
- 2
- Regulation number
- 866.3350
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Dowingtown, PA, 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 |
|---|---|---|
| LEPTOSPIROSIS IHA (K880417) | Hillcrest Biologicals | 1988-04-12 |
Recalls involving this device
No recalls on record reference this clearance.