Cleared Traditional

K883470 - IDS-1600 SAMPLE HANDLING SYSTEM

K883470 is an FDA 510(k) clearance for IDS-1600 SAMPLE HANDLING SYSTEM, manufactured by Baxter Healthcare Corp. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K883470 · Baxter Healthcare Corp · Chemistry device
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Dec 1988
Decision
116d
Days
Class 1
Risk

K883470 is an FDA 510(k) clearance for the IDS-1600 SAMPLE HANDLING SYSTEM. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Baxter Healthcare Corp (Waukegan, US). The FDA issued a Cleared decision on December 9, 1988 after a review of 116 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K883470

510(k) Number K883470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 1988
Decision Date December 09, 1988
Days to Decision 116 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
28d slower than avg
Panel avg: 88d · This submission: 116d
Pathway characteristics
Predicate-based equivalence.

JQW Device Classification - Class 1, General Controls

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JQW Station, Pipetting And Diluting, For Clinical Use

All 83
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K883470.
DELTA (TM) ROBOTIC PIPETTOR
K893031 · Diagnostic Products Corp. · Jun 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · Hichem Diagnostics · Mar 1989
AIR DISPLACEMENT PIPETTE
K885340 · Ulster Scientific, Inc. · Feb 1989
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · Dynatech Laboratories, Inc. · Jun 1988
MULTI-ACCESS REAGENT DISPENSER
K873416 · Electro-Nucleonics Laboratories, Inc. · Oct 1987
DYNATECH SPD 3000, #002-900-0000
K872363 · Dynatech Laboratories, Inc. · Jul 1987