Cleared Traditional

K945368 - PHOSPHORUS TEST (PHOS)

K945368 is the FDA 510(k) clearance for PHOSPHORUS TEST (PHOS) by Emd Chemicals, Inc.. It is a Class 1 Chemistry device (product code CEO) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K945368 · Emd Chemicals, Inc. · Chemistry device
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Dec 1994
Decision
43d
Days
Class 1
Risk

K945368 is an FDA 510(k) clearance for the PHOSPHORUS TEST (PHOS). Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Emd Chemicals, Inc. (Gibbstown, US). The FDA issued a Cleared decision on December 2, 1994 after a review of 43 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 Emd Chemicals, Inc. devices

Submission Details

510(k) Number K945368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1994
Decision Date December 02, 1994
Days to Decision 43 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 88d · This submission: 43d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 73
Devices cleared under the same product code (CEO) and FDA review panel - the closest regulatory comparables to K945368.
RANDOX INORGANIC PHOSPHOROUS
K974605 · Randox Laboratories, Ltd. · Jan 1998
OLYMPUS INORGANIC PHOSPHORUS REAGENT
K944768 · Olympus America, Inc. · Mar 1995
PHOSPHORUS TEST (PHOS) ITEM NUMBER 65416
K945322 · Emd Chemicals, Inc. · Dec 1994
EMDS PHOSPHOROUS (PHOS) TEST
K935178 · Em Diagnostic Systems, Inc. · Dec 1993
OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT
K931835 · Olympus Corp. · Sep 1993
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (PHOS)
K932729 · Eastman Kodak Company · Aug 1993