Cleared Traditional

K771143 - INORGANIC PHOSPHORUS STANDARDS

K771143 is the FDA 510(k) clearance for INORGANIC PHOSPHORUS STANDARDS by Worthington Biochemical Corp.. It is a Class 2 Hematology device (product code JIT) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K771143 · Worthington Biochemical Corp. · Hematology device
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Jul 1977
Decision
14d
Days
Class 2
Risk

K771143 is an FDA 510(k) clearance for the INORGANIC PHOSPHORUS STANDARDS. Classified as Calibrator, Secondary (product code JIT), Class II - Special Controls.

Submitted by Worthington Biochemical Corp. (Mchenry, US). The FDA issued a Cleared decision on July 11, 1977 after a review of 14 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1150 - the FDA hematology device 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 Worthington Biochemical Corp. devices

Submission Details

510(k) Number K771143 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 1977
Decision Date July 11, 1977
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 113d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 Hematology devices follow this clearance model.

Regulatory Peers - JIT Calibrator, Secondary

All 172
Devices cleared under the same product code (JIT) and FDA review panel - the closest regulatory comparables to K771143.
ACA AMMONIA CALIBRATOR
K771804 · E.I. Dupont DE Nemours & Co., Inc. · Oct 1977
CENTRIFICHEM TRIGLYCERIDE CALI. STD.
K771215 · Union Carbide Corp. · Jul 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
CHOLESTEROL CALIBRATOR
K761197 · Beckman Instruments, Inc. · Dec 1976