Cleared Traditional

K933996 - PROFIBLOT (FDA 510(k) Clearance)

Class I Pathology device.

K933996 · Tecan U.S., Ltd. · Pathology device
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Jan 1994
Decision
164d
Days
Class 1
Risk

K933996 is an FDA 510(k) clearance for the PROFIBLOT. Classified as Slide Stainer, Automated (product code KPA), Class I - General Controls.

Submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on January 28, 1994 after a review of 164 days - an extended review cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.3800 - the FDA pathology 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 Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Tecan U.S., Ltd. devices

Submission Details

510(k) Number K933996 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 17, 1993
Decision Date January 28, 1994
Days to Decision 164 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d slower than avg
Panel avg: 77d · This submission: 164d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KPA Slide Stainer, Automated
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.3800
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.