Cleared Traditional

K941764 - HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808

K941764 is an FDA 510(k) clearance for HICHEM CALCIUM REAGENT FOR THE SYNCHRON..., manufactured by Hi Chem, Inc.. The device is a Class 2 Chemistry device with product code CJY cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K941764 · Hi Chem, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1994
Decision
45d
Days
Class 2
Risk

K941764 is an FDA 510(k) clearance for the HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808. Classified as Azo Dye, Calcium (product code CJY), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Brea, US). The FDA issued a Cleared decision on May 13, 1994 after a review of 45 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1145 - 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 Hi Chem, Inc. devices

FDA 510(k) Submission Details - K941764

510(k) Number K941764 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1994
Decision Date May 13, 1994
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 88d · This submission: 45d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CJY Device Classification - Class 2, Special Controls

Product Code CJY Azo Dye, Calcium
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1145
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 Chemistry devices follow this clearance model.

Regulatory Peers - CJY Azo Dye, Calcium

All 43
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