Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL

Manual Antimicrobial Susceptibility Test Systems

Liofilchem S.r.l.

The following data is part of a premarket notification filed by Liofilchem S.r.l. with the FDA for Liofilchem Mic Test Strip (mts)- Clindamycin 0.016 - 256 µg/ml.

Pre-market Notification Details

• Device ID: K170772
• 510k Number: K170772
• Device Name: Liofilchem MIC Test Strip (MTS)- Clindamycin 0.016 - 256 µg/mL
• Classification: Manual Antimicrobial Susceptibility Test Systems
• Applicant: Liofilchem S.r.l. Via Scozia Zona Ind.le Roseto Degli Abruzzi, IT 64026
• Contact: Fabio Brocco
• Correspondent: Laura M. Koeth; Laboratory Specialists, Inc 1651-A Crossings Parkway Westlake, OH 44145
• Product Code: JWY
• CFR Regulation Number: 866.1640 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-03-14
• Decision Date: 2017-06-07

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08055182870127	K170772	000