Cleared Traditional

K883470 - IDS-1600 SAMPLE HANDLING SYSTEM

K883470 is the FDA 510(k) clearance for IDS-1600 SAMPLE HANDLING SYSTEM by Baxter Healthcare Corp. It is a Class 1 Chemistry device (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

Submission Details

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.

Device Classification

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 63
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K883470.
DU PONT DIMENSION PSID CLINICAL CHEMISTRY SYSTEM
K893775 · E.I. Dupont DE Nemours & Co., Inc. · Jul 1989
DELTA (TM) ROBOTIC PIPETTOR
K893031 · Diagnostic Products Corp. · Jun 1989
HI CHEM WASH CONCENTRATE REAGENT #88805
K890578 · Hichem Diagnostics · Mar 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