Cleared Traditional

K830535 - FLOW-PAC ALKALINE PHOSPHATE REAGENT SET

K830535 is the FDA 510(k) clearance for FLOW-PAC ALKALINE PHOSPHATE REAGENT SET by Amresco, Inc.. It is a Class 2 Chemistry device (product code CJF) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K830535 · Amresco, Inc. · Chemistry device
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Mar 1983
Decision
34d
Days
Class 2
Risk

K830535 is an FDA 510(k) clearance for the FLOW-PAC ALKALINE PHOSPHATE REAGENT SET. Classified as Tetrabromophenolphthalein, Albumin (product code CJF), Class II - Special Controls.

Submitted by Amresco, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1035 - 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 Amresco, Inc. devices

Submission Details

510(k) Number K830535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 1983
Decision Date March 24, 1983
Days to Decision 34 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
54d faster than avg
Panel avg: 88d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CJF Tetrabromophenolphthalein, 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 Chemistry devices follow this clearance model.