The following data is part of a premarket notification filed by Pharmacia Diagnostics, Inc. with the FDA for Delfia(r) 17 -oh-progesteron Kit.
| Device ID | K912026 |
| 510k Number | K912026 |
| Device Name: | DELFIA(R) 17 -OH-PROGESTERON KIT |
| Classification | Radioimmunoassay, 17-hydroxyprogesterone |
| Applicant | PHARMACIA DIAGNOSTICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Contact | Judith J Smith |
| Correspondent | Judith J Smith PHARMACIA DIAGNOSTICS, INC. 8310 GUILFORD RD. Columbia, MD 21046 |
| Product Code | JLX |
| CFR Regulation Number | 862.1395 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-07 |
| Decision Date | 1991-06-25 |