The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Rubella Antibody Assay, Lan.0200/2200.
| Device ID | K882475 |
| 510k Number | K882475 |
| Device Name: | AMERLITE RUBELLA ANTIBODY ASSAY, LAN.0200/2200 |
| Classification | Enzyme Linked Immunoabsorbent Assay, Rubella |
| Applicant | AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Contact | Frank J Lyman |
| Correspondent | Frank J Lyman AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights, IL 60005 |
| Product Code | LFX |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-15 |
| Decision Date | 1988-10-06 |