The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Prl-quant.
| Device ID | K883269 |
| 510k Number | K883269 |
| Device Name: | PRL-QUANT |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Contact | Lee, Ph.d. |
| Correspondent | Lee, Ph.d. LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-03 |
| Decision Date | 1988-09-13 |