The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Hcg-60 Assay, Lan.0083/2083 240kit/144kit.
| Device ID | K881355 |
| 510k Number | K881355 |
| Device Name: | AMERLITE HCG-60 ASSAY, LAN.0083/2083 240KIT/144KIT |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-18 |
| Decision Date | 1988-06-08 |