The following data is part of a premarket notification filed by Birmingham with the FDA for Immunoglobulin G & G Subclasses.
| Device ID | K875356 |
| 510k Number | K875356 |
| Device Name: | IMMUNOGLOBULIN G & G SUBCLASSES |
| Classification | Igg, Antigen, Antiserum, Control |
| Applicant | BIRMINGHAM WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Contact | Jay H Geller |
| Correspondent | Jay H Geller BIRMINGHAM WESTSIDE TOWERS, SUITE 1000 11845 WEST OLYMPIC BLVD. Los Angeles, CA 90064 |
| Product Code | DEW |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-31 |
| Decision Date | 1988-02-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05051700010948 | K875356 | 000 |
| 05051700010931 | K875356 | 000 |
| 05051700010924 | K875356 | 000 |
| 05051700010917 | K875356 | 000 |
| 05051700010443 | K875356 | 000 |
| 05051700010399 | K875356 | 000 |
| 05051700010368 | K875356 | 000 |