510(k) K831671

MODIFIED SOYBEAN CASEIN DIGEST BROTH by Isle Media and Sterile Products, Inc. — Product Code JSG

K831671 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "MODIFIED SOYBEAN CASEIN DIGEST BROTH". The FDA issued a decision of Substantially Equivalent on July 28, 1983. The device falls under product code JSG (Culture Media, Non-Selective And Non-Differential), a Class I device regulated under 21 CFR 866.2300. Isle Media and Sterile Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 1983
Date Received
May 23, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Non-Selective And Non-Differential
Device Class
Class I
Regulation Number
866.2300
Review Panel
MI
Submission Type