The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Unicap 100.
| Device ID | K962274 |
| 510k Number | K962274 |
| Device Name: | UNICAP 100 |
| Classification | System, Test, Radioallergosorbent (rast) Immunological |
| 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 | DHB |
| CFR Regulation Number | 866.5750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-13 |
| Decision Date | 1996-09-12 |
| Summary: | summary |