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510(k) K923268

AFFIRM PROCESSOR by Microprobe Corp. — Product Code JQW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1992
Date Received
July 6, 1992
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 Microprobe Corp.

  • K931151 — AFFIRM(TM) VPIII MICROBIAL IDENT TEST FOR CANDIDA (June 18, 1993)
  • K931374 — AFFIRM VPIII MICROBIAL IDENTIFICATION TEST (June 15, 1993)
  • K923133 — AFFIRM/VP IDENT.TEST G.VAGINALIS & T.VAGINALIS (September 25, 1992)
  • K922457 — AFFIRM VP MICROBIAL ID TEST FOR TRICHOMONAS VAGINA (September 25, 1992)
  • K920536 — AFFIRM VP SAMPLE COLLECTION SET (July 30, 1992)

Other clearances for product code JQW

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  • K973335 — QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (April 30, 1998)
  • 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)