The following data is part of a premarket notification filed by Nichols Institute Diagnostics with the FDA for Allegro(tm) Luteinizing Hormone Immunoassay.
| Device ID | K881124 |
| 510k Number | K881124 |
| Device Name: | ALLEGRO(TM) LUTEINIZING HORMONE IMMUNOASSAY |
| 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 | 1988-03-16 |
| Decision Date | 1988-04-18 |