The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite(tm) Prolactin-30 Assay, Lan.0086/2086.
Device ID | K914135 |
510k Number | K914135 |
Device Name: | AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086 |
Classification | Radioimmunoassay, Prolactin (lactogen) |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Kathryn B Patterson |
Correspondent | Kathryn B Patterson 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 | 1991-09-16 |
Decision Date | 1992-02-18 |