510(k) K926364

ATTEST BRAND RAPID READOUT BIOLOGICAL IND. #129X by 3M Health Care, Ltd. — Product Code FRC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 31, 1995
Date Received
December 22, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Indicator, Biological Sterilization Process
Device Class
Class II
Regulation Number
880.2800
Review Panel
HO
Submission Type