510(k) K792594

TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE. by Isle Media and Sterile Products, Inc. — Product Code JSG

K792594 is an FDA 510(k) premarket notification submitted by Isle Media and Sterile Products, Inc. for the device "TRYPTIC SOY AGAR W/LECITHIN & POLYSRBTE.". The FDA issued a decision of Substantially Equivalent on December 31, 1979. 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
December 31, 1979
Date Received
December 17, 1979
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