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510(k) K902592

EPC ELECTRONIC PIPETTING SYSTEM by Ulster Scientific, Inc. — Product Code JQW

K902592 is an FDA 510(k) premarket notification submitted by Ulster Scientific, Inc. for the device "EPC ELECTRONIC PIPETTING SYSTEM". The FDA issued a decision of Substantially Equivalent on Jul 19, 1990. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Ulster Scientific, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Jul 19, 1990
Date Received
Jun 12, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Station, Pipetting And Diluting, For Clinical Use
Device Class
Class I
Regulation Number
862.2750
Review Panel
CH
Submission Type

Other clearances by Ulster Scientific, Inc.

  • K942620 — FEATHER-TOUCH SINGLE-STICK DEVICE (Jun 22, 1994)
  • K920562 — UNISTIK (Mar 27, 1992)
  • K895890 — AUTOPEN (Feb 16, 1990)
  • K894474 — THE AUTOLET LITE (Aug 18, 1989)
  • K885340 — AIR DISPLACEMENT PIPETTE (Feb 14, 1989)
  • K875354 — UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM (Feb 17, 1988)
  • K871571 — NEUROTIPS(TM) (Jun 18, 1987)
  • K871076 — WINPETTE (Mar 23, 1987)
  • K870078 — ACCUPEN(R) (Mar 17, 1987)
  • K864761 — USI AUTOJECT INSULIN SYRINGE (Dec 16, 1986)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (Jun 24, 2003)
  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (Apr 30, 1998)
  • K980180 — 2700 SAMPLE MANAGER (Feb 12, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (Jun 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (Apr 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (Mar 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (Oct 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (Aug 16, 1996)
  • K961694 — IMPACT (Jun 21, 1996)
  • K953345 — GENESIS (Nov 21, 1995)

FDA data resources