Cleared Traditional

K811749 - KING DIAGNOSTICS PHOSPHORUS TEST

K811749 is an FDA 510(k) clearance for KING DIAGNOSTICS PHOSPHORUS TEST, manufactured by King Diagnostics, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K811749 · King Diagnostics, Inc. · Chemistry device
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Jul 1981
Decision
18d
Days
Class 1
Risk

K811749 is an FDA 510(k) clearance for the KING DIAGNOSTICS PHOSPHORUS TEST. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by King Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 10, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1580 - 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 King Diagnostics, Inc. devices

FDA 510(k) Submission Details - K811749

510(k) Number K811749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date July 10, 1981
Days to Decision 18 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
70d faster than avg
Panel avg: 88d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

CEO Device Classification - Class 1, General Controls

Product Code CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1580
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - CEO Phosphomolybdate (colorimetric), Inorganic Phosphorus

All 97
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K811749.
PSI INORGANIC PHOSPHORUS
K822470 · Pointe Scientific, Inc., · Sep 1982
ULTRACHEM PHOS
K821874 · Harleco Diagnostics · Jul 1982
INORGANIC PHOSPHORUS REAGENT SET
K813400 · Anco Medical Reagents & Assoc. · Dec 1981
REAGENT FOR DETERM. INORGANIC/PHOSPHORUS
K800690 · Diagnostic Solutions, Inc. · May 1980
SANDARE FAST 340 PHOSPHOROUS PROCEDURE
K800297 · Sandare Chemical Co., Inc. · Mar 1980
ELVI INORGANIC PHOSPHOROUS
K792401 · Volu Sol Medical Industries · Dec 1979