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510(k) K913962

ANOMALOSCOPE QUADRANT TEST-6 by Lkc Technologies, Inc. — Product Code HIW

K913962 is an FDA 510(k) premarket notification submitted by Lkc Technologies, Inc. for the device "ANOMALOSCOPE QUADRANT TEST-6". The FDA issued a decision of Substantially Equivalent on October 23, 1991. The device falls under product code HIW (Anomaloscope), a Class I device regulated under 21 CFR 886.1070. Lkc Technologies, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1991
Date Received
September 5, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anomaloscope
Device Class
Class I
Regulation Number
886.1070
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)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • 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 HIW

  • K930575 — KAMPPETER ANOMALOSCOPE (February 25, 1994)
  • K860174 — GUNKEL CHROMAGRAPH COLOR VISION TESTER (April 4, 1986)

FDA data resources