510(k) K962744

HAEMOPHILUS TEST MEDIUM AGAR (HTM) by Prepared Media Laboratory, Inc. — Product Code JSO

K962744 is an FDA 510(k) premarket notification submitted by Prepared Media Laboratory, Inc. for the device "HAEMOPHILUS TEST MEDIUM AGAR (HTM)". The FDA issued a decision of Substantially Equivalent on October 15, 1996. The device falls under product code JSO (Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar), a Class II device regulated under 21 CFR 866.1700. Prepared Media Laboratory, Inc. has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 1996
Date Received
July 15, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type