Home / 510(k) Clearances / K862066

510(k) K862066

TITERTEK MICROPLATE WASHER S-12 by Flow Laboratories, Inc. — Product Code JTC

K862066 is an FDA 510(k) premarket notification submitted by Flow Laboratories, Inc. for the device "TITERTEK MICROPLATE WASHER S-12". The FDA issued a decision of Substantially Equivalent on June 5, 1986. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Flow Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 5, 1986
Date Received
May 30, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Microtiter Diluting/Dispensing
Device Class
Class I
Regulation Number
866.2500
Review Panel
MI
Submission Type

Other clearances by Flow Laboratories, Inc.

  • K861897 — UNISKAN II (July 1, 1986)
  • K861823 — GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) (May 20, 1986)
  • K861791 — PENICILLIN-STREPTOMYCIN-FUNGIZONE (May 20, 1986)
  • K861824 — GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) (May 20, 1986)
  • K860762 — GAMMA-FREE HORSE SERUM (March 10, 1986)
  • K860752 — GOAT SERUM (29-391-54) (March 10, 1986)
  • K850908 — TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA (March 25, 1985)
  • K844419 — TITERTEK MULTISKAN MSS/340 (March 21, 1985)
  • K844418 — TITERTEK MULTISKAN MCC (March 21, 1985)
  • K844567 — TITERTEK TWINREADER 78-630-00 (March 21, 1985)

Other clearances for product code JTC

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • K894645 — IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (October 17, 1989)
  • K892369 — MULTI-PROBE HEAD PLUS (June 2, 1989)
  • K891765 — GENETIC SYSTEMS PIPETTOR/DILUTOR (May 1, 1989)
  • K891768 — GENETIC SYSTEMS MICROPLATE WASHER (May 1, 1989)
  • K891766 — GENETIC SYSTEMS MICROPLATE STRIP WASHER (May 1, 1989)
  • K884695 — WASHER 500 MICROELISA SYSTEM (December 13, 1988)
  • K884125 — BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (December 2, 1988)
  • K874598 — DYNATECH MR 250 MANUAL MICROELISA READER (November 20, 1987)

FDA data resources