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510(k) K871945

MICROLAB AT by Hamilton Co. — Product Code JTC

K871945 is an FDA 510(k) premarket notification submitted by Hamilton Co. for the device "MICROLAB AT". The FDA issued a decision of Substantially Equivalent on May 29, 1987. The device falls under product code JTC (Device, Microtiter Diluting/Dispensing), a Class I device regulated under 21 CFR 866.2500. Hamilton Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 29, 1987
Date Received
May 19, 1987
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 Hamilton Co.

  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K943493 — DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER (January 30, 1995)
  • K892369 — MULTI-PROBE HEAD PLUS (June 2, 1989)
  • K873893 — LUMICON (January 5, 1988)
  • K832202 — PB 600 REPEATING DISPENSER (August 24, 1983)
  • K832204 — MICROLAB P (August 24, 1983)
  • K832205 — PRECISION LIQUID DISPENSER (August 24, 1983)
  • K832199 — HC40/HC75 CATION EXCHANGE RESIN (August 16, 1983)
  • K832201 — CHROM-PREP (August 16, 1983)
  • K832200 — PRP-1 REVERSED PHASE COLUMNS FOR HPLC (August 16, 1983)

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