The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Immuchem Covalent Coat A Solid Phase Radioimmunoas.
| Device ID | K854094 |
| 510k Number | K854094 |
| Device Name: | IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOAS |
| Classification | Radioimmunoassay, Progesterone |
| Applicant | IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Contact | Barry J Burns |
| Correspondent | Barry J Burns IMMUCHEM CORP. P.O. BOX 6227 2015 EAST UNIVERSITY DRIVE Carson, CA 90746 |
| Product Code | JLS |
| CFR Regulation Number | 862.1620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-07 |
| Decision Date | 1986-02-28 |