Cleared Traditional

K842847 - WAKO AUTOMATED REAGENTS FOR HITACHI 705

K842847 is an FDA 510(k) clearance for WAKO AUTOMATED REAGENTS FOR HITACHI 705, manufactured by Wako Chemicals USA, Inc.. The device is a Class 2 Hematology device with product code CJW cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K842847 · Wako Chemicals USA, Inc. · Hematology device
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Dec 1984
Decision
144d
Days
Class 2
Risk

K842847 is an FDA 510(k) clearance for the WAKO AUTOMATED REAGENTS FOR HITACHI 705. Classified as Bromcresol Purple Dye-binding, Albumin (product code CJW), Class II - Special Controls.

Submitted by Wako Chemicals USA, Inc. (Dallas, US). The FDA issued a Cleared decision on December 11, 1984 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1035 - the FDA hematology device 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 Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Wako Chemicals USA, Inc. devices

FDA 510(k) Submission Details - K842847

510(k) Number K842847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1984
Decision Date December 11, 1984
Days to Decision 144 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 113d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJW Device Classification - Class 2, Special Controls

Product Code CJW Bromcresol Purple Dye-binding, Albumin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1035
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - CJW Bromcresol Purple Dye-binding, Albumin

All 17
Devices cleared under the same product code (CJW) and FDA review panel - the closest regulatory comparables to K842847.
VISION ALBUMIN
K862138 · Abbott Laboratories · Jun 1986
A-GENT LIQUID ALBUMIN
K860423 · Abbott Laboratories · Mar 1986
ALBUMIN BCP
K844426 · Boehringer Mannheim Corp. · Jan 1985
ALBUMIN PROCEDURE BCP
K832632 · Sandare Chemical Co., Inc. · Sep 1983
QUANTIMETRIX BROMERESOL PURPLE ALBUMIN
K830934 · Quantimetrix Corp. · Apr 1983