510(k) K870451

SKIN GRAFT PRESERVATION MEDIUM (TISSUE) by Bioclinical Laboratory Services, Inc. — Product Code KIT

K870451 is an FDA 510(k) premarket notification submitted by Bioclinical Laboratory Services, Inc. for the device "SKIN GRAFT PRESERVATION MEDIUM (TISSUE)". The FDA issued a decision of Substantially Equivalent on May 26, 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
May 26, 1987
Date Received
February 3, 1987
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