Cleared Traditional

CRYOCHECK LA SURE, MODEL SUR25-10 (K990580) - FDA 510(k) Clearance

Class I Hematology device.

K990580 · Precision Biologic · Hematology device
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Jul 1999
Decision
155d
Days
Class 1
Risk

K990580 is an FDA 510(k) clearance for the CRYOCHECK LA SURE, MODEL SUR25-10. Classified as Reagent, Russel Viper Venom (product code GIR), Class I - General Controls.

Submitted by Precision Biologic (Dartmouth, N.S., CA). The FDA issued a Cleared decision on July 28, 1999 after a review of 155 days - an extended review cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.8950 - 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 Precision Biologic devices

Submission Details

510(k) Number K990580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1999
Decision Date July 28, 1999
Days to Decision 155 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 113d · This submission: 155d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code GIR Reagent, Russel Viper Venom
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.8950
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.