Cleared Traditional

K971907 - CALCIUM REAGENT

K971907 is an FDA 510(k) clearance for CALCIUM REAGENT, manufactured by Carolina Liquid Chemistries Corp.. The device is a Class 2 Chemistry device with product code CIC cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K971907 · Carolina Liquid Chemistries Corp. · Chemistry device
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Jun 1997
Decision
32d
Days
Class 2
Risk

K971907 is an FDA 510(k) clearance for the CALCIUM REAGENT. Classified as Cresolphthalein Complexone, Calcium (product code CIC), Class II - Special Controls.

Submitted by Carolina Liquid Chemistries Corp. (Brea, US). The FDA issued a Cleared decision on June 24, 1997 after a review of 32 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 Carolina Liquid Chemistries Corp. devices

FDA 510(k) Submission Details - K971907

510(k) Number K971907 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1997
Decision Date June 24, 1997
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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.

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All 84
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