The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Lh Serozyme Immunoenzymetric Assay Kit,mag Sol Pha.
| Device ID | K882340 |
| 510k Number | K882340 |
| Device Name: | LH SEROZYME IMMUNOENZYMETRIC ASSAY KIT,MAG SOL PHA |
| Classification | Radioimmunoassay, Luteinizing Hormone |
| Applicant | SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Contact | Philip M Fantasia |
| Correspondent | Philip M Fantasia SERONO DIAGNOSTICS, INC. 100 LONGWATER CIRCLE Norwell, MA 02061 |
| Product Code | CEP |
| CFR Regulation Number | 862.1485 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-07 |
| Decision Date | 1988-08-08 |