The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Prl-quant Diagnostic Test Kit.
| Device ID | K820039 |
| 510k Number | K820039 |
| Device Name: | LEECO PRL-QUANT DIAGNOSTIC TEST KIT |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| Applicant | LEECO DIAGNOSTICS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-07 |
| Decision Date | 1982-01-22 |