Cleared Traditional

RSP MEGA SAMPLE PROCESSOR

K915492 · Tecan U.S., Ltd. · Chemistry
Feb 1992
Decision
79d
Days
Class 1
Risk

About This 510(k) Submission

K915492 is an FDA 510(k) clearance for the RSP MEGA SAMPLE PROCESSOR, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on February 21, 1992, 79 days after receiving the submission on December 4, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K915492 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1991
Decision Date February 21, 1992
Days to Decision 79 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JQW — Station, Pipetting And Diluting, For Clinical Use
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.2750

Similar Devices — JQW Station, Pipetting And Diluting, For Clinical Use

All 139
BD VIPER INSTRUMENT
K023955 · Becton, Dickinson & CO · Jun 2003
QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE)
K973335 · Zenyx Scientific , Ltd. · Apr 1998
2700 SAMPLE MANAGER
K980180 · Waters Corporation · Feb 1998
MASTERCAP AM 5.0/MASTERCAP RM 5.0
K970420 · Pharmacia, Inc. · Jun 1997
MINI SAMPLER PROCESSOR
K970616 · Cavro Scientific Instruments, Inc. · Apr 1997
GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM
K962687 · Nichols Institute Diagnostics · Mar 1997