The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Estradiol Assay, Lan.2080 (144 Test Kit).
| Device ID | K884105 |
| 510k Number | K884105 |
| Device Name: | AMERLITE ESTRADIOL ASSAY, LAN.2080 (144 TEST KIT) |
| Classification | Radioimmunoassay, Estradiol |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Rhonda A Martin |
| Correspondent | Rhonda A Martin AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | CHP |
| CFR Regulation Number | 862.1260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-09-29 |
| Decision Date | 1988-11-16 |