Cleared Traditional

K800848 - SERALYZER URIC ACID REAGENT STRIPS -

K800848 is an FDA 510(k) clearance for SERALYZER URIC ACID REAGENT STRIPS -, manufactured by Miles Laboratories, Inc.. The device is a Class 1 Chemistry device with product code KNK cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K800848 · Miles Laboratories, Inc. · Chemistry device
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Apr 1980
Decision
9d
Days
Class 1
Risk

K800848 is an FDA 510(k) clearance for the SERALYZER URIC ACID REAGENT STRIPS -. Classified as Acid, Uric, Uricase (colorimetric) (product code KNK), Class I - General Controls.

Submitted by Miles Laboratories, Inc. (Walker, US). The FDA issued a Cleared decision on April 24, 1980 after a review of 9 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1775 - 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 Miles Laboratories, Inc. devices

FDA 510(k) Submission Details - K800848

510(k) Number K800848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 1980
Decision Date April 24, 1980
Days to Decision 9 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
79d faster than avg
Panel avg: 88d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

KNK Device Classification - Class 1, General Controls

Product Code KNK Acid, Uric, Uricase (colorimetric)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.1775
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 - KNK Acid, Uric, Uricase (colorimetric)

All 100
Devices cleared under the same product code (KNK) and FDA review panel - the closest regulatory comparables to K800848.
LANCER URIC ACID AUTO/STAT KIT
K802692 · Sherwood Medical Co. · Dec 1980
AMES SERA-PAK URIC ACID REAGENT KIT
K802724 · Miles Laboratories, Inc. · Dec 1980
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES
K801649 · Eastman Kodak Company · Aug 1980
URIC ACID REAGENT
K791754 · Gilford Diagnostics · Sep 1979
FLOZYME* URIC ACID REAGENT
K790486 · Worthington Diagnostic Systems · Apr 1979
URIC ACID, BOUND ENZYME
K790092 · Technicon Instruments Corp. · Mar 1979