Cleared Traditional

K952126 - AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II

K952126 is an FDA 510(k) clearance for AALTO SCIENTIFIC LIQUID CEREBROSPINAL F..., manufactured by Aalto Scientific, Ltd.. The device is a Class 2 Hematology device with product code GGP cleared through the Traditional 510(k) pathway after a 297-day FDA review.

K952126 · Aalto Scientific, Ltd. · Hematology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1996
Decision
297d
Days
Class 2
Risk

K952126 is an FDA 510(k) clearance for the AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II. Classified as Test, Qualitative And Quantitative Factor Deficiency (product code GGP), Class II - Special Controls.

Submitted by Aalto Scientific, Ltd. (Vista, US). The FDA issued a Cleared decision on February 29, 1996 after a review of 297 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.7290 - 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 Aalto Scientific, Ltd. devices

FDA 510(k) Submission Details - K952126

510(k) Number K952126 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1995
Decision Date February 29, 1996
Days to Decision 297 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
184d slower than avg
Panel avg: 113d · This submission: 297d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GGP Device Classification - Class 2, Special Controls

Product Code GGP Test, Qualitative And Quantitative Factor Deficiency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.7290
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 - GGP Test, Qualitative And Quantitative Factor Deficiency

All 149
Devices cleared under the same product code (GGP) and FDA review panel - the closest regulatory comparables to K952126.
SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY
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K962489 · Medical Diagnostic Technologies, Inc. · Jul 1996
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K960438 · Medical Diagnostic Technologies, Inc. · Jun 1996
BIOCLOT PROTEIN S
K955738 · Medical Diagnostic Technologies, Inc. · Feb 1996
CHROM Z-F:VIII, CAT. NO. 5241
K952668 · Helena Laboratories · Feb 1996
CHROM Z-PROTEIN C, CAT. NO. 5243
K952666 · Helena Laboratories · Jan 1996