The following data is part of a premarket notification filed by Immuchem Corp. with the FDA for Hprolactin Kit.
| Device ID | K871542 |
| 510k Number | K871542 |
| Device Name: | HPROLACTIN KIT |
| Classification | Radioimmunoassay, Prolactin (lactogen) |
| 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 | CFT |
| CFR Regulation Number | 862.1625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-04-20 |
| Decision Date | 1987-05-14 |