Cleared Traditional

K800297 - SANDARE FAST 340 PHOSPHOROUS PROCEDURE

K800297 is an FDA 510(k) clearance for SANDARE FAST 340 PHOSPHOROUS PROCEDURE, manufactured by Sandare Chemical Co., Inc.. The device is a Class 1 Chemistry device with product code CEO cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K800297 · Sandare Chemical Co., Inc. · Chemistry device
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Mar 1980
Decision
23d
Days
Class 1
Risk

K800297 is an FDA 510(k) clearance for the SANDARE FAST 340 PHOSPHOROUS PROCEDURE. Classified as Phosphomolybdate (colorimetric), Inorganic Phosphorus (product code CEO), Class I - General Controls.

Submitted by Sandare Chemical Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on March 5, 1980 after a review of 23 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 Sandare Chemical Co., Inc. devices

FDA 510(k) Submission Details - K800297

510(k) Number K800297 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 11, 1980
Decision Date March 05, 1980
Days to Decision 23 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
65d faster than avg
Panel avg: 88d · This submission: 23d
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 K800297.
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
ELVI INORGANIC PHOSPHOROUS
K792401 · Volu Sol Medical Industries · Dec 1979
INORGANIC PHOSPHORUS REAGENT
K791708 · Gilford Diagnostics · Sep 1979
SERUM, INORGANIC PHOSPHOROUS
K790021 · Fisher Scientific Co., LLC · Feb 1979