Cleared Traditional

K800848 - SERALYZER URIC ACID REAGENT STRIPS -

K800848 is the FDA 510(k) clearance for SERALYZER URIC ACID REAGENT STRIPS - by Miles Laboratories, Inc.. It is a Class 1 Chemistry device (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

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

Submission Details

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.

Device Classification

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 79

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

URIC ACID, BOUND ENZYME

K790092 · Technicon Instruments Corp. · Mar 1979

UNIPAK URIC ACID

K771088 · Harleco · Jul 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K800848

Miles Laboratories, Inc.

Walker, MI · US

Regulatory profile

158 submissions 158 cleared

100% clearance rate · Active in Chemistry

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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