510(k) K012326

WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 by Wiener Laboratories Saic — Product Code JGJ

K012326 is an FDA 510(k) premarket notification submitted by Wiener Laboratories Saic for the device "WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001". The FDA issued a decision of Substantially Equivalent on November 8, 2001. The device falls under product code JGJ (Photometric Method, Magnesium), a Class I device regulated under 21 CFR 862.1495. Wiener Laboratories Saic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 8, 2001
Date Received
July 23, 2001
Clearance Type
Traditional
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