The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Luteinizing Hormone Radioimmuno-kit.
Device ID | K851104 |
510k Number | K851104 |
Device Name: | AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT |
Classification | Radioimmunoassay, Luteinizing Hormone |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Philip M Frantasia |
Correspondent | Philip M Frantasia AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | CEP |
CFR Regulation Number | 862.1485 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-03-19 |
Decision Date | 1985-04-10 |