Kreda Disc
FDA 510(k) K874252 · Richmond Products, Inc.
510(k) numberK874252
Submission
- Device name
- Kreda Disc
- Applicant
- Richmond Products, Inc.
Boca Raton, FL, US - Received
- October 19, 1987
- Decision date
- January 27, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HOQ – Grid, Amsler
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.1330
- Specialty
- Ophthalmic
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| K843227 | Macular Function AnalyzerHOQ · Traditional | Danek Medical, Inc. | 07/22/1985SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K874251 | Worth 4 Dot Test Distance C/W Muscle LightHLP · Traditional | 01/11/1988SE |
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| K873907 | Confirmation TestsHPC · Traditional | 12/29/1987SE |
| K873908 | H.R.R. Pseudoisochromatic Color Blindness Test Bk.HIT · Traditional | 12/23/1987SE |
| K873916 | 'E' Cube and 'E' PadHOX · Traditional | 12/11/1987SE |
| K873914 | Animated Fixation Toys (Distance and Nearpoint)HPL · Traditional | 12/11/1987SE |
| K873913 | Color Book Illuminator StandHJD · Traditional | 12/02/1987SE |
| K873911 | Pseudo Isochromatic Color Blindness Test Book - 15HIT · Traditional | 12/02/1987SE |
| K873917 | Tonometer TapesHKX · Traditional | 11/02/1987SE |
| K873912 | Richmond Visual Field ScreenerHOO · Traditional | 11/02/1987SE |
Questions and answers
When was Kreda Disc cleared by the FDA?
Kreda Disc (K874252) received a 510(k) decision of Substantially Equivalent on January 27, 1988, 100 days after the submission was received.
What is the product code of K874252?
The FDA product code is HOQ – Grid, Amsler, a Class I (low risk) device regulated under 21 CFR 886.1330.