Cleared Traditional

K852790 - ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT

K852790 is an FDA 510(k) clearance for ANALYZER: NOVA STAT PROFILE 1 QUA CON M..., manufactured by Nova Biomedical Corp.. The device is a Class 2 Hematology device with product code CHL cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K852790 · Nova Biomedical Corp. · Hematology device
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Nov 1985
Decision
134d
Days
Class 2
Risk

K852790 is an FDA 510(k) clearance for the ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Nova Biomedical Corp. (Walham, US). The FDA issued a Cleared decision on November 12, 1985 after a review of 134 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 862.1120 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Nova Biomedical Corp. devices

FDA 510(k) Submission Details - K852790

510(k) Number K852790 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1985
Decision Date November 12, 1985
Days to Decision 134 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d slower than avg
Panel avg: 113d · This submission: 134d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 157
Devices cleared under the same product code (CHL) and FDA review panel - the closest regulatory comparables to K852790.
ABL330 ACID BASE LABORATORY
K860057 · Radiometer America, Inc. · Mar 1986
LIFE WATCH RESPIRATORY MONITOR
K853840 · The Perkin-Elmer Corp. · Dec 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608 · Nova Biomedical Corp. · Dec 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781 · Shaban Mfg. Co. · Feb 1985
ABL300 ACID BASE LABORATORY
K844295 · Radiometer America, Inc. · Dec 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609 · Shaban Mfg. Co. · May 1984