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510(k) K883749

PROBE(TM) MODELS 700 AND 1000 by Packard Instrument Co., Inc. — Product Code JQW

K883749 is an FDA 510(k) premarket notification submitted by Packard Instrument Co., Inc. for the device "PROBE(TM) MODELS 700 AND 1000". The FDA issued a decision of Substantially Equivalent on November 10, 1988. The device falls under product code JQW (Station, Pipetting And Diluting, For Clinical Use), a Class I device regulated under 21 CFR 862.2750. Packard Instrument Co., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1988
Date Received
September 1, 1988
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 Packard Instrument Co., Inc.

  • K924907 — FILTERMATE UNIVERSAL HARVESTER (December 1, 1992)
  • K913664 — ROSYS MODELS 100 AND 200 (August 30, 1991)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)

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