FDA 510(k), K002024, PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
FDA 510(k), K002024, PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
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510(K) Number: K002024
Device Name: PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
Manufacturer: PANBIO, INC.
Device Classification Name: antigens, all, leptospira spp.
Regulation Number: 866.3350
Classification Product Code: GRY
Date Received: 07/03/2000
Decision Date: 11/22/2000
Regulation Medical Specialty: Microbiology
Device Name: PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA
Manufacturer: PANBIO, INC.
Device Classification Name: antigens, all, leptospira spp.
Regulation Number: 866.3350
Classification Product Code: GRY
Date Received: 07/03/2000
Decision Date: 11/22/2000
Regulation Medical Specialty: Microbiology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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