FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANOMALOSCOPE PLATE TEST - 5 [APT-5]
K Number: K875026
·
Decision Feb 5, 1988
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
8
Applicant Total
8
Review Days
60
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Basic Information
- Device Name
- ANOMALOSCOPE PLATE TEST - 5 [APT-5]
- K Number
- K875026
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 886.1170
- Medical Specialty
- Ophthalmic
- Decision
- Substantially Equivalent
- Applicant
- Lkc Technologies, Inc.
- Date Received
- December 7, 1987
- Decision Date
- February 5, 1988
- Product Code
- HIT
- Advisory Committee
- Ophthalmic
- Review Advisory Committee
- OP
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| HIT | Tester, Color Vision | FDA class 1 | Ophthalmic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HIT), ordered by most recent decision date.
SLIMCATH (TM)
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TITMUS VISION TESTER II
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COLOR VISION TESTERS
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FDA Class 1
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OSCAR COLOUR VISION TESTER
FDA 510(k)
FDA Class 1
·Ophthalmic
Other Clearances by Lkc Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142567 | RETeval Visual Electrodiagnostic Device | May 19, 2015 | Substantially Equivalent |
| K914163 | SCOPTOPIC SENSITIVITY TEST-1[SST-1] | Oct 25, 1991 | Substantially Equivalent |
| K913962 | ANOMALOSCOPE QUADRANT TEST-6 | Oct 23, 1991 | Substantially Equivalent |
| K874336 | PATTERN DISCRIMINATION PERIMETER | Jan 12, 1988 | Substantially Equivalent |
| K820414 | UNIVERSAL TESTING & ANALYSIS SYSTEMS | Mar 4, 1982 | Substantially Equivalent |
| K790109 | TELEMETRY, BIOMEDICAL | Mar 16, 1979 | Substantially Equivalent |
| K760199 | ELECTRORETINOGRAPH | Aug 4, 1976 | Substantially Equivalent |