The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m B-human Chorionic Gonadtropin Radioi Kit.
Device ID | K852675 |
510k Number | K852675 |
Device Name: | AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT |
Classification | Visual, Pregnancy Hcg, Prescription Use |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Philip M Fantasia |
Correspondent | Philip M Fantasia 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 | 1985-06-24 |
Decision Date | 1985-07-22 |