The following data is part of a premarket notification filed by Phadia Us Inc. with the FDA for Cardiolipin Autoantibody Immunological Test System.
| Device ID | K091845 |
| 510k Number | K091845 |
| Device Name: | CARDIOLIPIN AUTOANTIBODY IMMUNOLOGICAL TEST SYSTEM |
| Classification | System, Test, Anticardiolipin Immunological |
| Applicant | PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Contact | Martin Robert Mann |
| Correspondent | Martin Robert Mann PHADIA US INC. 4169 COMMERCIAL AVE. Portage, MI 49002 |
| Product Code | MID |
| Subsequent Product Code | JJY |
| Subsequent Product Code | MSV |
| CFR Regulation Number | 866.5660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-22 |
| Decision Date | 2010-06-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333066010809 | K091845 | 000 |
| 07333066013992 | K091845 | 000 |
| 07333066020082 | K091845 | 000 |
| 07333066013923 | K091845 | 000 |
| 07333066013947 | K091845 | 000 |
| 07333066013954 | K091845 | 000 |
| 07333066013961 | K091845 | 000 |
| 07333066013978 | K091845 | 000 |
| 07333066010748 | K091845 | 000 |
| 07333066010762 | K091845 | 000 |
| 07333066010779 | K091845 | 000 |
| 07333066010793 | K091845 | 000 |
| 07333066013985 | K091845 | 000 |