The following data is part of a premarket notification filed by Clark Laboratories, Inc. with the FDA for Encore Ds-dna.
| Device ID | K923537 |
| 510k Number | K923537 |
| Device Name: | ENCORE DS-DNA |
| Classification | Anti-dna Antibody (enzyme-labeled), Antigen, Control |
| Applicant | CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Contact | Gary Lehnus |
| Correspondent | Gary Lehnus CLARK LABORATORIES, INC. 53 CEDAR LAKE RD. Blairstown, NJ 07825 |
| Product Code | LRM |
| CFR Regulation Number | 866.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-16 |
| Decision Date | 1992-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391516747141 | K923537 | 000 |
| 05391516743723 | K923537 | 000 |