510(k) K883629

HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013 by J R Scientific — Product Code KIT

K883629 is an FDA 510(k) premarket notification submitted by J R Scientific for the device "HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013". The FDA issued a decision of Substantially Equivalent on September 7, 1988. 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. J R Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 7, 1988
Date Received
August 22, 1988
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