The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Luteinizing Hormone (lh-irma) Ria Kit.
| Device ID | K864144 |
| 510k Number | K864144 |
| Device Name: | LUTEINIZING HORMONE (LH-IRMA) RIA KIT |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Contact | Burns, Phd |
| Correspondent | Burns, Phd IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-10-22 |
| Decision Date | 1986-11-24 |