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 |