Submission Details
| 510(k) Number | K873908 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 1987 |
| Decision Date | December 23, 1987 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
K873908 is an FDA 510(k) clearance for the H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK., a Tester, Color Vision (Class I — General Controls, product code HIT), submitted by Richmond Products, Inc. (Boca Raton, US). The FDA issued a Cleared decision on December 23, 1987, 89 days after receiving the submission on September 25, 1987. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.1170.
| 510(k) Number | K873908 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 1987 |
| Decision Date | December 23, 1987 |
| Days to Decision | 89 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | — |
| Product Code | HIT — Tester, Color Vision |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 886.1170 |