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510(k) K830157

DIGIFLEX AUTOMATIC PIPETTE by Micromedic Systems — Product Code JQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1983
Date Received
January 18, 1983
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

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  • K871008 — MICROMEDIC NEONATAL T4 KIT (May 26, 1987)
  • K870904 — MICROMEDIC NEONATAL TSH MONOCLONAL IRMA KIT (May 26, 1987)
  • K870245 — AUTOPAK TSH MONOCLONAL IRMA KIT (April 1, 1987)
  • K862206 — TAURUS (TM) AUTOMATIC LIQUID SCINTILLATION COUNTER (August 4, 1986)
  • K860813 — MICROMEDIC HTSH MONOCLONAL IRMA KIT (July 14, 1986)
  • K861262 — MMS T3 UPTAKE (May 23, 1986)
  • K861320 — MMS T4 RIA KIT (April 24, 1986)

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  • K980180 — 2700 SAMPLE MANAGER (February 12, 1998)
  • K970420 — MASTERCAP AM 5.0/MASTERCAP RM 5.0 (June 30, 1997)
  • K970616 — MINI SAMPLER PROCESSOR (April 21, 1997)
  • K962687 — GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (March 28, 1997)
  • K962859 — MINI SAMPLE PROCESSOR (October 29, 1996)
  • K961896 — MICROLAB 4000, MICROLAB 4200 (August 16, 1996)
  • K961694 — IMPACT (June 21, 1996)
  • K953345 — GENESIS (November 21, 1995)