Cleared Traditional

K002536 - LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CO...

K002536 is the FDA 510(k) clearance for LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CO... by Bio-Rad. It is a Class 1 Chemistry device (product code JJS) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K002536 · Bio-Rad · Chemistry device
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Aug 2000
Decision
14d
Days
Class 1
Risk

K002536 is an FDA 510(k) clearance for the LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER). Classified as Controls For Blood-gases, (assayed And Unassayed) (product code JJS), Class I - General Controls.

Submitted by Bio-Rad (Irvine, US). The FDA issued a Cleared decision on August 30, 2000 after a review of 14 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 Bio-Rad devices

Submission Details

510(k) Number K002536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 2000
Decision Date August 30, 2000
Days to Decision 14 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 88d · This submission: 14d
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 K002536.
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865 · Bio-Rad · Sep 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
K002866 · Bio-Rad · Sep 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535 · Bio-Rad · Aug 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120 · Bio-Rad · Aug 2000
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
K980135 · Radiometer America, Inc. · Jan 1998
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861 · Instrumentation Laboratory CO · Aug 1997