Cleared Traditional

K844316 - RAICHEM PHOSPHORUS REAGENT

K844316 is an FDA 510(k) clearance for RAICHEM PHOSPHORUS REAGENT, manufactured by Reagents Applications, Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K844316 · Reagents Applications, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
48d
Days
Class 1
Risk

K844316 is an FDA 510(k) clearance for the RAICHEM PHOSPHORUS REAGENT. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Reagents Applications, Inc. (San Diego, US). The FDA issued a Cleared decision on January 3, 1985 after a review of 48 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 Reagents Applications, Inc. devices

FDA 510(k) Submission Details - K844316

510(k) Number K844316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 16, 1984
Decision Date January 03, 1985
Days to Decision 48 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
40d faster than avg
Panel avg: 88d · This submission: 48d
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 K844316.
INORGANIC PHOSPHORUS LIQUID STABLE REAGENT INORGAN
K852103 · Medical Analysis Systems, Inc. · May 1985
DATE CHEM INORGANIC PHOSPHOROUS U.V. PROCEDURE
K850986 · Data Medical Associates, Inc. · Apr 1985
INORGANIC PHOSPHOROUS FOR DEMAND ANALYZER
K850380 · Advanced Biomedical Methods, Inc. · Mar 1985
INORGANIC PHOSPHORUS TEST
K843177 · Sclavo, Inc. · Sep 1984
SYSTEMATE PHOSPHORUS 67217
K843330 · Em Diagnostic Systems, Inc. · Sep 1984
INORGANIC PHOSPHORUS ASSAY KIT
K843030 · Diagnostic Chemicals, Ltd. (Usa) · Aug 1984