Cleared Traditional

K801449 - BLOOD GAS CONTROL PROD. NO. BG-1

K801449 is the FDA 510(k) clearance for BLOOD GAS CONTROL PROD. NO. BG-1 by Health Diagnostics Corp.. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K801449 · Health Diagnostics Corp. · Chemistry device
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Jul 1980
Decision
28d
Days
Class 1
Risk

K801449 is an FDA 510(k) clearance for the BLOOD GAS CONTROL PROD. NO. BG-1, BG-2. Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Health Diagnostics Corp. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980 after a review of 28 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 Health Diagnostics Corp. devices

Submission Details

510(k) Number K801449 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1980
Decision Date July 21, 1980
Days to Decision 28 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
60d faster than avg
Panel avg: 88d · This submission: 28d
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 49
Devices cleared under the same product code (JJS) and FDA review panel - the closest regulatory comparables to K801449.
PROTEIN-BASED BLOOD GAS CONTROL
K812541 · American Dade · Sep 1981
AQUEOUS BLOOD GAS CONTROLS
K812553 · Fisher Scientific Co., LLC · Sep 1981
PH/BLOOD GAS CONTROL (ABC)
K811143 · Instrumentation Laboratory CO · May 1981
REFEREE BFT BLOOD FOR TONOMETRY
K792447 · Analytical Products, Inc. · Dec 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143 · Fisher Scientific Co., LLC · Nov 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180 · Corning Medical & Scientific · Nov 1979