The following data is part of a premarket notification filed by Mbl International Corporation with the FDA for Mesacup Models Bp180 And Bp230 Elisa Kits.
| Device ID | K071961 |
| 510k Number | K071961 |
| Device Name: | MESACUP MODELS BP180 AND BP230 ELISA KITS |
| Classification | Autoantibodies, Skin (bullous Pemphigoid 180 And Bullous Pemphigoid 230 |
| Applicant | MBL INTERNATIONAL CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm MBL INTERNATIONAL CORPORATION PO BOX 7007 Deerfield, IL 60015 |
| Product Code | OEG |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-07-16 |
| Decision Date | 2008-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B110RGM7613D0 | K071961 | 000 |
| B110RGM7612D0 | K071961 | 000 |