Cleared Traditional

K843895 - TOTAL CALCIUM REAGENT SET

K843895 is the FDA 510(k) clearance for TOTAL CALCIUM REAGENT SET by Livonia Diagnostics, Inc.. It is a Class 2 Chemistry device (product code CIC) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K843895 · Livonia Diagnostics, Inc. · Chemistry device
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Oct 1984
Decision
27d
Days
Class 2
Risk

K843895 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 Livonia Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1984 after a review of 27 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 Livonia Diagnostics, Inc. devices

Submission Details

510(k) Number K843895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 1984
Decision Date October 30, 1984
Days to Decision 27 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 88d · This submission: 27d
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 69
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K843895.
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CALCIUM
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RAICHEM CALCIUM REAGENT
K843353 · Reagents Applications, Inc. · Sep 1984
SYSTEMATE CALCIUM 67214
K843152 · Em Diagnostic Systems, Inc. · Aug 1984
CALCIUM ASSAY KIT
K842509 · Diagnostic Chemicals, Ltd. (Usa) · Jul 1984