510(k) K900726

MICROTEK MEDICAL'S BLOOD COLLECTION KIT by Microbio-Medics, Inc. — Product Code JKA

K900726 is an FDA 510(k) premarket notification submitted by Microbio-Medics, Inc. for the device "MICROTEK MEDICAL'S BLOOD COLLECTION KIT". The FDA issued a decision of Substantially Equivalent on May 4, 1990. The device falls under product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection), a Class II device regulated under 21 CFR 862.1675. Microbio-Medics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 4, 1990
Date Received
February 15, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Vials, Systems, Serum Separators, Blood Collection
Device Class
Class II
Regulation Number
862.1675
Review Panel
CH
Submission Type