510(k) K770764

TISSUE CULTURE MEDIA W/HEPES BUFFER by Microbiological Assoc. — Product Code KIT

K770764 is an FDA 510(k) premarket notification submitted by Microbiological Assoc. for the device "TISSUE CULTURE MEDIA W/HEPES BUFFER". The FDA issued a decision of Substantially Equivalent on July 21, 1977. The device falls under product code KIT (Media And Components, Synthetic Cell And Tissue Culture), a Class I device regulated under 21 CFR 864.2220. Microbiological Assoc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 21, 1977
Date Received
April 27, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Media And Components, Synthetic Cell And Tissue Culture
Device Class
Class I
Regulation Number
864.2220
Review Panel
PA
Submission Type