Anomaloscope Plate Test - 5 [APT-5]
FDA 510(k) K875026 · Lkc Technologies, Inc.
510(k) numberK875026
Submission
- Device name
- Anomaloscope Plate Test - 5 [APT-5]
- Applicant
- Lkc Technologies, Inc.
Gaithersburg, MD, US - Received
- December 7, 1987
- Decision date
- February 5, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HIT – Tester, Color Vision
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1170
- Specialty
- Ophthalmic
Other 510(k)s with product code HIT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K903001 | Slimcath (TM)HIT · Traditional | Gynopharma, Inc. | 06/25/1991SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | Richmond Products, Inc. | 12/23/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | Richmond Products, Inc. | 12/02/1987SE |
| K844694 | Titmus Vision Tester IIHIT · Traditional | Titmus Optical, Inc. | 01/22/1985SE |
| K844365 | Color Vision TestersHIT · Traditional | Luneau Laboratories | 01/02/1985SE |
| K832843 | Oscar Colour Vision TesterHIT · Traditional | Keeler Instruments, Inc. | 01/04/1984SE |
| K831074 | Oscar Color Vision TesterHIT · Traditional | Carl Zeiss, Inc. | 04/28/1983SE |
| K810700 | Chromops FM-100 Color Vision TesterHIT · Traditional | Visidyne Corp. | 04/10/1981SE |
More from Visidyne Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic DeviceGWE · Traditional | 05/19/2015SE |
| K914163 | Scoptopic Sensitivity TEST-1[SST-1]HLX · Traditional | 10/25/1991SE |
| K913962 | Anomaloscope Quadrant TEST-6HIW · Traditional | 10/23/1991SE |
| K874336 | Pattern Discrimination PerimeterHPT · Traditional | 01/12/1988SE |
| K820414 | Universal Testing & Analysis SystemsGWF · Traditional | 03/04/1982SE |
| K790109 | Telemetry, BiomedicalDRG · Traditional | 03/16/1979SE |
| K760199 | ElectroretinographHLZ · Traditional | 08/04/1976SE |
Questions and answers
When was Anomaloscope Plate Test - 5 [APT-5] cleared by the FDA?
Anomaloscope Plate Test - 5 [APT-5] (K875026) received a 510(k) decision of Substantially Equivalent on February 5, 1988, 60 days after the submission was received.
What is the product code of K875026?
The FDA product code is HIT – Tester, Color Vision, a Class I (low risk) device regulated under 21 CFR 886.1170.