Cleared Traditional

FLOW-PAC CALCIUM REAGENT SET (K834336) - FDA 510(k) Clearance

Class II Chemistry device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K834336 · American Research Products Co. · Chemistry device
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Feb 1984
Decision
71d
Days
Class 2
Risk

K834336 is an FDA 510(k) clearance for the FLOW-PAC CALCIUM REAGENT SET. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by American Research Products Co. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 71 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 American Research Products Co. devices

Submission Details

510(k) Number K834336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 12, 1983
Decision Date February 21, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 88d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code CIC Cresolphthalein Complexone, 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 - CIC Cresolphthalein Complexone, Calcium

All 21
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K834336.
A-GENT LIQUID CALCIUM
K860425 · Abbott Laboratories · Apr 1986
CALCIUM
K850281 · Boehringer Mannheim Corp. · Feb 1985
SYSTEMATE CALCIUM 67214
K843152 · Em Diagnostic Systems, Inc. · Aug 1984
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923 · Beckman Instruments, Inc. · Dec 1980
CALCIUM REAGENT SYSTEM NO. 585
K780983 · Sigma Chemical Co. · Jul 1978