510(k) K832860

SXT BLOOD AGAR by Troy Biologicals, Inc. — Product Code JSJ

K832860 is an FDA 510(k) premarket notification submitted by Troy Biologicals, Inc. for the device "SXT BLOOD AGAR". The FDA issued a decision of Substantially Equivalent on September 26, 1983. The device falls under product code JSJ (Culture Media, Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2360. Troy Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1983
Date Received
August 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type