Cleared Traditional

K890578 - HI CHEM WASH CONCENTRATE REAGENT #88805

K890578 is an FDA 510(k) clearance for HI CHEM WASH CONCENTRATE REAGENT #88805, manufactured by Hichem Diagnostics. The device is a Class 1 Chemistry device with product code JQW cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K890578 · Hichem Diagnostics · Chemistry device
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Mar 1989
Decision
32d
Days
Class 1
Risk

K890578 is an FDA 510(k) clearance for the HI CHEM WASH CONCENTRATE REAGENT #88805. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on March 10, 1989 after a review of 32 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Hichem Diagnostics devices

FDA 510(k) Submission Details - K890578

510(k) Number K890578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 06, 1989
Decision Date March 10, 1989
Days to Decision 32 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
56d faster than avg
Panel avg: 88d · This submission: 32d
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 K890578.
ABBOTT COMMANDER FLEXIBLE PIPETTING CENTER
K894069 · Abbott Laboratories · Aug 1989
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
AIR DISPLACEMENT PIPETTE
K885340 · Ulster Scientific, Inc. · Feb 1989
IDS-1600 SAMPLE HANDLING SYSTEM
K883470 · Baxter Healthcare Corp · Dec 1988
DYNATECH SPD 2000, NUMBER 002-910-0000
K881195 · Dynatech Laboratories, Inc. · Jun 1988