510(k) K092737

EASYRA MG REAGENT, MODEL 10220 by Medica Corp. — Product Code JGJ

K092737 is an FDA 510(k) premarket notification submitted by Medica Corp. for the device "EASYRA MG REAGENT, MODEL 10220". The FDA issued a decision of Substantially Equivalent on November 17, 2009. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Medica Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 17, 2009
Date Received
September 8, 2009
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Magnesium
Device Class
Class I
Regulation Number
862.1495
Review Panel
CH
Submission Type