Cleared Traditional

K771215 - CENTRIFICHEM TRIGLYCERIDE CALI. STD.

K771215 is an FDA 510(k) clearance for CENTRIFICHEM TRIGLYCERIDE CALI. STD., manufactured by Union Carbide Corp.. The device is a Class 2 Chemistry device with product code JIT cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K771215 · Union Carbide Corp. · Chemistry device
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Jul 1977
Decision
16d
Days
Class 2
Risk

K771215 is an FDA 510(k) clearance for the CENTRIFICHEM TRIGLYCERIDE CALI. STD.. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1977 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1150 - 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 Union Carbide Corp. devices

FDA 510(k) Submission Details - K771215

510(k) Number K771215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 1977
Decision Date July 21, 1977
Days to Decision 16 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
72d faster than avg
Panel avg: 88d · This submission: 16d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JIT Device Classification - Class 2, Special Controls

Product Code JIT Calibrator, Secondary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1150
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 - JIT Calibrator, Secondary

All 173
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K771215.
ACA IRON CALIBRATOR
K771802 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA PHOSPHORUS CALIBRATOR
K771803 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
ACA AMMONIA CALIBRATOR
K771804 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET
K771216 · Union Carbide Corp. · Jul 1977
CENTRIFICHEM CHOLES. CALIB. STD. SET
K770126 · Union Carbide Corp. · Jan 1977
CENTRIFICHEM 200MG/DL CHOL. CAL. STD.
K770127 · Union Carbide Corp. · Jan 1977