Cleared Traditional

K800616 - BUN REAGENT KIT #88108

K800616 is an FDA 510(k) clearance for BUN REAGENT KIT #88108, manufactured by Hi Chem, Inc.. The device is a Class 2 Chemistry device with product code CDS cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800616 · Hi Chem, Inc. · Chemistry device
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Apr 1980
Decision
23d
Days
Class 2
Risk

K800616 is an FDA 510(k) clearance for the BUN REAGENT KIT #88108. Classified as Electrode, Ion Specific, Urea Nitrogen (product code CDS), Class II - Special Controls.

Submitted by Hi Chem, Inc. (Walker, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 23 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1770 - 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 - K800616

510(k) Number K800616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1980
Decision Date April 10, 1980
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CDS Device Classification - Class 2, Special Controls

Product Code CDS Electrode, Ion Specific, Urea Nitrogen
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1770
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 - CDS Electrode, Ion Specific, Urea Nitrogen

All 9
Devices cleared under the same product code (CDS) and FDA review panel - the closest regulatory comparables to K800616.
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