The following data is part of a premarket notification filed by Serono Diagnostics, Inc. with the FDA for Hcg Maiaclone Immunoradiometric Kit/kit Components.
| Device ID | K862262 |
| 510k Number | K862262 |
| Device Name: | HCG MAIACLONE IMMUNORADIOMETRIC KIT/KIT COMPONENTS |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| 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 | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-13 |
| Decision Date | 1986-07-29 |