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510(k) K850251

ROTALOK SURGICAL HAND TABLE by Fairleigh Dickinson Laboratories, Inc.

K850251 is an FDA 510(k) premarket notification submitted by Fairleigh Dickinson Laboratories, Inc. for the device "ROTALOK SURGICAL HAND TABLE". The FDA issued a decision of Substantially Equivalent on February 28, 1985. Fairleigh Dickinson Laboratories, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 28, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Fairleigh Dickinson Laboratories, Inc.

  • K896032 — MODIFIED ELISA FOR CHLAMYDIA (January 29, 1990)
  • K895187 — FDL, INC.'S TRANSPORT SYSTEM (October 24, 1989)
  • K883266 — FDL ELISA FOR CHLAMYDIA (October 25, 1988)
  • K881502 — BREWER GEL FOR CAMPYLOBACTER (April 27, 1988)
  • K875362 — BREWER GEL FOR ANAEROBES (January 27, 1988)
  • K853307 — DIRECT ELISA FOR HERPES SIMPLEX VIRUS (December 23, 1985)

FDA data resources