510(k) K844934

AZIDE AGAR W/5% SHEEP BLOOD by American Laboratory Supply, Inc. — Product Code JSI

K844934 is an FDA 510(k) premarket notification submitted by American Laboratory Supply, Inc. for the device "AZIDE AGAR W/5% SHEEP BLOOD". The FDA issued a decision of Substantially Equivalent on February 25, 1985. The device falls under product code JSI (Culture Media, Selective And Differential), a Class I device regulated under 21 CFR 866.2360. American Laboratory Supply, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1985
Date Received
December 19, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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