COLOR VISION TESTERS
FDA 510(k) clearance K844365 · decided 1985-01-02
Clearance details
- K-number
- K844365
- Device name
- COLOR VISION TESTERS
- Applicant
- Luneau Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1984-11-13
- Decision date
- 1985-01-02
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- HIT
- Device class
- 1
- Regulation number
- 886.1170
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| SLIMCATH (TM) (K903001) | Gynopharma, Inc. | 1991-06-25 |
| ANOMALOSCOPE PLATE TEST - 5 [APT-5] (K875026) | Lkc Technologies, Inc. | 1988-02-05 |
| H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (K873908) | Richmond Products, Inc. | 1987-12-23 |
| PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (K873911) | Richmond Products, Inc. | 1987-12-02 |
| TITMUS VISION TESTER II (K844694) | Titmus Optical, Inc. | 1985-01-22 |
| OSCAR COLOUR VISION TESTER (K832843) | Keeler Instruments, Inc. | 1984-01-04 |
| OSCAR COLOR VISION TESTER (K831074) | Carl Zeiss, Inc. | 1983-04-28 |
| CHROMOPS FM-100 COLOR VISION TESTER (K810700) | Visidyne Corp. | 1981-04-10 |
Recalls involving this device
No recalls on record reference this clearance.