510(k) K864396

LYMPHOCYTE MAINTENANCE MEDIUM by Bioclinical Laboratory Services, Inc. — Product Code KIT

K864396 is an FDA 510(k) premarket notification submitted by Bioclinical Laboratory Services, Inc. for the device "LYMPHOCYTE MAINTENANCE MEDIUM". The FDA issued a decision of Substantially Equivalent on February 2, 1987. 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. Bioclinical Laboratory Services, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 1987
Date Received
November 6, 1986
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