Cleared Traditional

K850929 - CALCIUM

K850929 is an FDA 510(k) clearance for CALCIUM, manufactured by Dilab, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K850929 · Dilab, Inc. · Chemistry device
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Jun 1985
Decision
95d
Days
Class 2
Risk

K850929 is an FDA 510(k) clearance for the CALCIUM. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Dilab, Inc. (Miami, US). The FDA issued a Cleared decision on June 10, 1985 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Dilab, Inc. devices

FDA 510(k) Submission Details - K850929

510(k) Number K850929 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1985
Decision Date June 10, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 88d · This submission: 95d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CIC Device Classification - Class 2, Special Controls

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 90
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K850929.
CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ
K853050 · Simmler, Inc. · Aug 1985
AMRESCO CALCIUM REAGENT SET
K852657 · American Research Products Co. · Jul 1985
CA BUFFER CA DYE
K852002 · Alpkem Corp. · Jun 1985
CALCIUM
K850281 · Boehringer Mannheim Corp. · Feb 1985
CALCIUM REAGENT FOR DEMAND ANALYZER
K844241 · Advanced Biomedical Methods, Inc. · Jan 1985
TOTAL BILIRUBIN FOR DEMAND ANALYZER
K844243 · Advanced Biomedical Methods, Inc. · Jan 1985