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510(k) K842894

KEMBLE 405 by Kemble Instruments, Inc. — Product Code JQW

K842894 is an FDA 510(k) premarket notification submitted by Kemble Instruments, Inc. for the device "KEMBLE 405". The FDA issued a decision of Substantially Equivalent on August 27, 1984. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Kemble Instruments, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
July 23, 1984
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 Kemble Instruments, Inc.

  • K832760 — RIA SOFTWARE (October 14, 1983)
  • K832734 — KEMTEK 400 RIA GAMMA COUNTER (October 14, 1983)
  • K832735 — KEMTEK 103 RIA GAMMA COUNTER (September 29, 1983)
  • K832736 — KEMTEK 104 RIA GAMMA COUNTER (September 29, 1983)
  • K830751 — KEMTEK 102 (April 6, 1983)
  • K822293 — IMMU-COUNT 404 (August 24, 1982)
  • K827748 — THYRO-COUNT THYROID UPTAKE SYSTEM 90IZD PROBE (August 16, 1982)
  • K820137 — IMMU-COUNT (February 5, 1982)

Other clearances for product code JQW

  • K023955 — BD VIPER INSTRUMENT (June 24, 2003)
  • 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)

FDA data resources