Home / 510(k) Clearances / K913664

510(k) K913664

ROSYS MODELS 100 AND 200 by Packard Instrument Co., Inc. — Product Code JQW

K913664 is an FDA 510(k) premarket notification submitted by Packard Instrument Co., Inc. for the device "ROSYS MODELS 100 AND 200". The FDA issued a decision of Substantially Equivalent on August 30, 1991. 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
August 30, 1991
Date Received
August 16, 1991
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)
  • K901808 — MICROMATE 196 MODEL A961960 (June 20, 1990)
  • K883749 — PROBE(TM) MODELS 700 AND 1000 (November 10, 1988)

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