510(k) K864740

BONE MARROW COLLECTION MEDIUM by Bioclinical Laboratory Services, Inc. — Product Code KIT

K864740 is an FDA 510(k) premarket notification submitted by Bioclinical Laboratory Services, Inc. for the device "BONE MARROW COLLECTION MEDIUM". The FDA issued a decision of Substantially Equivalent on January 5, 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
January 5, 1987
Date Received
December 4, 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