The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Prolactin Assay, Lan.0078/2078(240/144).
Device ID | K883878 |
510k Number | K883878 |
Device Name: | AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144) |
Classification | Radioimmunoassay, Prolactin (lactogen) |
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 | CFT |
CFR Regulation Number | 862.1625 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-09-13 |
Decision Date | 1988-11-01 |