The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Camp(125)assay System Rpa.508 (100 Kit).
Device ID | K860253 |
510k Number | K860253 |
Device Name: | AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT) |
Classification | Radioimmunoassay, Cyclic Amp |
Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Contact | Dennis W Henkelman |
Correspondent | Dennis W Henkelman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
Product Code | CHO |
CFR Regulation Number | 862.1230 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-01-24 |
Decision Date | 1986-03-14 |