Cleared Traditional

K893778 - CALCIUM TEST ITEM NUMBER: 65409

K893778 is an FDA 510(k) clearance for CALCIUM TEST ITEM NUMBER: 65409, manufactured by Em Diagnostic Systems, Inc.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K893778 · Em Diagnostic Systems, Inc. · Chemistry device
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Sep 1989
Decision
106d
Days
Class 2
Risk

K893778 is an FDA 510(k) clearance for the CALCIUM TEST ITEM NUMBER: 65409. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on September 5, 1989 after a review of 106 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 Em Diagnostic Systems, Inc. devices

FDA 510(k) Submission Details - K893778

510(k) Number K893778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1989
Decision Date September 05, 1989
Days to Decision 106 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
18d slower than avg
Panel avg: 88d · This submission: 106d
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 89
Devices cleared under the same product code (CIC) and FDA review panel - the closest regulatory comparables to K893778.
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K884986 · Em Diagnostic Systems, Inc. · Jan 1989