The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Scoptopic Sensitivity Test-1[sst-1].
| Device ID | K914163 |
| 510k Number | K914163 |
| Device Name: | SCOPTOPIC SENSITIVITY TEST-1[SST-1] |
| Classification | Photostimulator, Ac-powered |
| Applicant | LKC TECHNOLOGIES, INC. 2 PROFESSIONAL DR., SUITE 222 Gaithersburg, MD 20879 |
| Contact | Jerome Leight |
| Correspondent | Jerome Leight LKC TECHNOLOGIES, INC. 2 PROFESSIONAL DR., SUITE 222 Gaithersburg, MD 20879 |
| Product Code | HLX |
| CFR Regulation Number | 886.1630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-17 |
| Decision Date | 1991-10-25 |