Cleared Traditional

K912536 - CALCITONIN KIT MITSUBISHI YUKA

K912536 is an FDA 510(k) clearance for CALCITONIN KIT MITSUBISHI YUKA, manufactured by Mitsubishi Yuka America, Inc.. The device is a Class 2 Chemistry device with product code JKR cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K912536 · Mitsubishi Yuka America, Inc. · Chemistry device
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Jul 1991
Decision
41d
Days
Class 2
Risk

K912536 is an FDA 510(k) clearance for the CALCITONIN KIT MITSUBISHI YUKA. Classified as Radioimmunoassay, Calcitonin (product code JKR), Class II - Special Controls.

Submitted by Mitsubishi Yuka America, Inc. (Washington, US). The FDA issued a Cleared decision on July 18, 1991 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1140 - 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 Mitsubishi Yuka America, Inc. devices

FDA 510(k) Submission Details - K912536

510(k) Number K912536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 1991
Decision Date July 18, 1991
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JKR Device Classification - Class 2, Special Controls

Product Code JKR Radioimmunoassay, Calcitonin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1140
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 - JKR Radioimmunoassay, Calcitonin

All 16
Devices cleared under the same product code (JKR) and FDA review panel - the closest regulatory comparables to K912536.
SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY)
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