Cleared Traditional

K802159 - AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS

K802159 is an FDA 510(k) clearance for AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS, manufactured by Panmed, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K802159 · Panmed, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1980
Decision
32d
Days
Class 1
Risk

K802159 is an FDA 510(k) clearance for the AMMONIUM MOLYBDATE INORGANIC PHOSPHORUS. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980 after a review of 32 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K802159

510(k) Number K802159 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1980
Decision Date October 10, 1980
Days to Decision 32 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 88d · This submission: 32d
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 98
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K802159.
ULTRACHEM PHOS
K821874 · Harleco Diagnostics · Jul 1982
INORGANIC PHOSPHORUS REAGENT SET
K813400 · Anco Medical Reagents & Assoc. · Dec 1981
KING DIAGNOSTICS PHOSPHORUS TEST
K811749 · King Diagnostics, Inc. · Jul 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