Cleared Traditional

K812835 - TOTAL CALCIUM REAGENT SET

K812835 is the FDA 510(k) clearance for TOTAL CALCIUM REAGENT SET by Anco Medical Reagents & Assoc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway .

K812835 · Anco Medical Reagents & Assoc. · Chemistry device
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Oct 1981
Decision
-
Days
Class 2
Risk

K812835 is an FDA 510(k) clearance for the TOTAL CALCIUM REAGENT SET. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Anco Medical Reagents & Assoc. (Mchenry, US). The FDA issued a Cleared decision on October 9, 1981.

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 Anco Medical Reagents & Assoc. devices

Submission Details

510(k) Number K812835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received October 09, 1981
Decision Date October 09, 1981
Days to Decision -
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
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 70
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K812835.
PSI CALCIUM REAGENT
K822469 · Pointe Scientific, Inc., · Sep 1982
WAKO CALCIUM C TEST
K820241 · Wako Chemicals USA, Inc. · Feb 1982
ASTRA-T CALCIUM REAGENT
K820090 · Hi Chem, Inc. · Jan 1982
GILCHEM CALCIUM REAGENT
K812110 · Gilford Diagnostics · Aug 1981
KING DIAGNOSTICS CALCIUM TEST
K811748 · King Diagnostics, Inc. · Jul 1981
BECKMAN ASTRA SYSTEMS CALCIUM CHEMISTRY
K802923 · Beckman Instruments, Inc. · Dec 1980