510(k) K944275

DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG. by Difco Laboratories, Inc. — Product Code JTN

K944275 is an FDA 510(k) premarket notification submitted by Difco Laboratories, Inc. for the device "DISPENS-O-DISC PIPERACILLIN 100 MCG./TAZOBACTAM 10 MCG.". The FDA issued a decision of Substantially Equivalent on December 19, 1994. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Difco Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 19, 1994
Date Received
August 30, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Susceptibility Test Discs, Antimicrobial
Device Class
Class II
Regulation Number
866.1620
Review Panel
MI
Submission Type