The following data is part of a premarket notification filed by Leeco Diagnostics, Inc. with the FDA for Leeco Progesterone-quant Diagnostic Test Kit.
Device ID | K850056 |
510k Number | K850056 |
Device Name: | LEECO PROGESTERONE-QUANT DIAGNOSTIC TEST KIT |
Classification | Radioimmunoassay, Progesterone |
Applicant | LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Contact | James P Lee |
Correspondent | James P Lee LEECO DIAGNOSTICS, INC. 21705 EVERGREEN P.O. BOX 5126 Southfield, MI 48075 |
Product Code | JLS |
CFR Regulation Number | 862.1620 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-01-08 |
Decision Date | 1985-02-06 |