The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Anti-dsdna Kit, Im.77/771 (50/100 Test Kits).
| Device ID | K893036 |
| 510k Number | K893036 |
| Device Name: | ANTI-DSDNA KIT, IM.77/771 (50/100 TEST KITS) |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| 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 | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-04-24 |
| Decision Date | 1989-06-02 |