The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Chemiluminescence Lh.
Device ID | K935319 |
510k Number | K935319 |
Device Name: | CHEMILUMINESCENCE LH |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
Contact | Dave D Smith |
Correspondent | Dave D Smith NICHOLS INSTITUTE DIAGNOSTICS 33608 ORTEGA HIGHWAY San Juan Capistrano, CA 92690 -6130 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-10-20 |
Decision Date | 1995-04-05 |