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510(k) K875026

ANOMALOSCOPE PLATE TEST - 5 [APT-5] by Lkc Technologies, Inc. — Product Code HIT

K875026 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "ANOMALOSCOPE PLATE TEST - 5 [APT-5]". The FDA issued a decision of Substantially Equivalent on February 5, 1988. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
December 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Color Vision
Device Class
Class I
Regulation Number
886.1170
Review Panel
OP
Submission Type

Other clearances by Lkc Technologies, Inc.

  • K142567 — RETeval Visual Electrodiagnostic Device (May 19, 2015)
  • K914163 — SCOPTOPIC SENSITIVITY TEST-1[SST-1] (October 25, 1991)
  • K913962 — ANOMALOSCOPE QUADRANT TEST-6 (October 23, 1991)
  • K874336 — PATTERN DISCRIMINATION PERIMETER (January 12, 1988)
  • K820414 — UNIVERSAL TESTING & ANALYSIS SYSTEMS (March 4, 1982)
  • K790109 — TELEMETRY, BIOMEDICAL (March 16, 1979)
  • K760199 — ELECTRORETINOGRAPH (August 4, 1976)

Other clearances for product code HIT

  • K903001 — SLIMCATH (TM) (June 25, 1991)
  • K873908 — H.R.R. PSEUDOISOCHROMATIC COLOR BLINDNESS TEST BK. (December 23, 1987)
  • K873911 — PSEUDO ISOCHROMATIC COLOR BLINDNESS TEST BOOK - 15 (December 2, 1987)
  • K844694 — TITMUS VISION TESTER II (January 22, 1985)
  • K844365 — COLOR VISION TESTERS (January 2, 1985)
  • K832843 — OSCAR COLOUR VISION TESTER (January 4, 1984)
  • K831074 — OSCAR COLOR VISION TESTER (April 28, 1983)
  • K810700 — CHROMOPS FM-100 COLOR VISION TESTER (April 10, 1981)

FDA data resources