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 |