Cleared Traditional

PROBE(TM) MODELS 700 AND 1000

K883749 · Packard Instrument Co., Inc. · Chemistry
Nov 1988
Decision
70d
Days
Class 1
Risk

About This 510(k) Submission

K883749 is an FDA 510(k) clearance for the PROBE(TM) MODELS 700 AND 1000, a Station, Pipetting And Diluting, For Clinical Use (Class I — General Controls, product code JQW), submitted by Packard Instrument Co., Inc. (Downers Grove, US). The FDA issued a Cleared decision on November 10, 1988, 70 days after receiving the submission on September 1, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2750.

Submission Details

510(k) Number K883749 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1988
Decision Date November 10, 1988
Days to Decision 70 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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

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