Cleared Traditional

ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X

K926364 · 3M Health Care, Ltd. · General Hospital
Mar 1995
Decision
829d
Days
Class 2
Risk

About This 510(k) Submission

K926364 is an FDA 510(k) clearance for the ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X, a Indicator, Biological Sterilization Process (Class II — Special Controls, product code FRC), submitted by 3M Health Care, Ltd. (St. Paul, US). The FDA issued a Cleared decision on March 31, 1995, 829 days after receiving the submission on December 22, 1992. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.2800.

Submission Details

510(k) Number K926364 FDA.gov
FDA Decision Cleared SESE
Date Received December 22, 1992
Decision Date March 31, 1995
Days to Decision 829 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FRC — Indicator, Biological Sterilization Process
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.2800

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