Cleared Traditional

K832003 - AQUEOUS BLOOD GAS CONTROL LEVEL I

K832003 is the FDA 510(k) clearance for AQUEOUS BLOOD GAS CONTROL LEVEL I by American Dade. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K832003 · American Dade · Chemistry device

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Aug 1983

Decision

49d

Days

Class 1

Risk

K832003 is an FDA 510(k) clearance for the AQUEOUS BLOOD GAS CONTROL LEVEL I,II &. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by American Dade (Walker, US). The FDA issued a Cleared decision on August 10, 1983 after a review of 49 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1660 - 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 American Dade devices

Submission Details

510(k) Number	K832003 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 22, 1983
Decision Date	August 10, 1983
Days to Decision	49 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

39d faster than avg

Panel avg: 88d · This submission: 49d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	JJS Controls For Blood-gases, (assayed And Unassayed)
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 862.1660

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 - JJS Controls For Blood-gases, (assayed And Unassayed)

All 43

Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K832003.

MULTI FUNCTION BLOOD GAS CONTROL

K851911 · Bionostics, Inc. · May 1985

BLOOD GAS CONTROL, LEVEL I(ACIDOSIS

K841783 · Bionostics, Inc. · Jun 1984

AQUEOUS BLOOD GAS CONTROL

K833146 · Bionostics, Inc. · Nov 1983

CERTAIN HB CO-OXIMETER CONTROL

K832028 · Corning Medical & Scientific · Jul 1983

REFEREE BLOOD GAS ANALYZER CONTROLS

K830181 · Analytical Products, Inc. · Feb 1983

CORNING CERTAIN TM

K820873 · Corning Medical & Scientific · Apr 1982

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 K832003

American Dade

Walker, MI · US

Regulatory profile

149 submissions 149 cleared

100% clearance rate · Active in Chemistry

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