The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro Luteinizing Hormone Immunoassay System.
Device ID | K863679 |
510k Number | K863679 |
Device Name: | ALLEGRO LUTEINIZING HORMONE IMMUNOASSAY SYSTEM |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Contact | Elaine Walton |
Correspondent | Elaine Walton NICHOLS INSTITUTE DIAGNOSTICS P.O. BOX 92797 Los Angeles, CA 90009 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-09-19 |
Decision Date | 1986-10-16 |