Home / 510(k) Clearances / K844365

510(k) K844365

COLOR VISION TESTERS by Luneau Laboratories — Product Code HIT

K844365 is an FDA 510(k) premarket notification submitted by Luneau Laboratories for the device "COLOR VISION TESTERS". The FDA issued a decision of Substantially Equivalent on January 2, 1985. The device falls under product code HIT (Tester, Color Vision), a Class I device regulated under 21 CFR 886.1170. Luneau Laboratories has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 2, 1985
Date Received
November 13, 1984
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 Luneau Laboratories

  • K850068 — LUNE AU CURETTES (April 8, 1985)
  • K844364 — SKIASCOPIC RACKS (January 2, 1985)
  • K844362 — OPHTHALMIC CHAIR (December 11, 1984)
  • K844363 — OPHTHALMIC STAND (December 5, 1984)

Other clearances for product code HIT

  • K903001 — SLIMCATH (TM) (June 25, 1991)
  • K875026 — ANOMALOSCOPE PLATE TEST - 5 [APT-5] (February 5, 1988)
  • 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)
  • 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