The following data is part of a premarket notification filed by Lkc Technologies, Inc. with the FDA for Anomaloscope Plate Test - 5 [apt-5].
Device ID | K875026 |
510k Number | K875026 |
Device Name: | ANOMALOSCOPE PLATE TEST - 5 [APT-5] |
Classification | Tester, Color Vision |
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 | HIT |
CFR Regulation Number | 886.1170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-07 |
Decision Date | 1988-02-05 |