510(k) K892728

IFA SENSIBAC NORFLOXACIN by Investigacion Farmaceutica S.A. DE C.V. — Product Code JTN

K892728 is an FDA 510(k) premarket notification submitted by Investigacion Farmaceutica S.A. DE C.V. for the device "IFA SENSIBAC NORFLOXACIN". The FDA issued a decision of Substantially Equivalent on September 21, 1989. The device falls under product code JTN (Susceptibility Test Discs, Antimicrobial), a Class II device regulated under 21 CFR 866.1620. Investigacion Farmaceutica S.A. DE C.V. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 1989
Date Received
April 14, 1989
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