The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Unicap Total Ige Assay/pharmacia Total Ige Controls Lmh.
| Device ID | K964152 |
| 510k Number | K964152 |
| Device Name: | UNICAP TOTAL IGE ASSAY/PHARMACIA TOTAL IGE CONTROLS LMH |
| Classification | Ige, Antigen, Antiserum, Control |
| Applicant | PHARMACIA, INC. 5094 ST. ANDREWS DR. Westervile, OH 43082 |
| Contact | Karen E Matis |
| Correspondent | Karen E Matis PHARMACIA, INC. 5094 ST. ANDREWS DR. Westervile, OH 43082 |
| Product Code | DGC |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-16 |
| Decision Date | 1997-04-23 |
| Summary: | summary |