The following data is part of a premarket notification filed by Panbio, Inc. with the FDA for Panbio Indx Igm Dip-s-ticks Leptospirosis Test For The Detection Of Igm Antibodies To Leptospira Biflexa.
| Device ID | K002024 |
| 510k Number | K002024 |
| Device Name: | PANBIO INDX IGM DIP-S-TICKS LEPTOSPIROSIS TEST FOR THE DETECTION OF IGM ANTIBODIES TO LEPTOSPIRA BIFLEXA |
| Classification | Antigens, All, Leptospira Spp. |
| Applicant | PANBIO, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Contact | David C Bishop |
| Correspondent | David C Bishop PANBIO, INC. 605 DILWORTH RD. Downingtown, PA 19335 |
| Product Code | GRY |
| CFR Regulation Number | 866.3350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-03 |
| Decision Date | 2000-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00613745000169 | K002024 | 000 |
| 00613745000152 | K002024 | 000 |
| 00613745000046 | K002024 | 000 |