510(k) K853546

ABBOTT CATION SUPPLEMENT SOLUTION by Abbott Laboratories — Product Code JSK

K853546 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ABBOTT CATION SUPPLEMENT SOLUTION". The FDA issued a decision of Substantially Equivalent on September 6, 1985. The device falls under product code JSK (Supplement, Culture Media), a Class I device regulated under 21 CFR 866.2450. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 6, 1985
Date Received
August 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Supplement, Culture Media
Device Class
Class I
Regulation Number
866.2450
Review Panel
MI
Submission Type