Cleared Traditional

PROFIBLOT

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

About This 510(k) Submission

K933996 is an FDA 510(k) clearance for the PROFIBLOT, a Slide Stainer, Automated (Class I — General Controls, product code KPA), submitted by Tecan U.S., Ltd. (Hillsborough, US). The FDA issued a Cleared decision on January 28, 1994, 164 days after receiving the submission on August 17, 1993. This device falls under the Pathology review panel. Regulated under 21 CFR 864.3800.

Submission Details

510(k) Number K933996 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KPA — Slide Stainer, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.3800

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