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510(k) K890689

ADX TM OPIATES by Abbott Laboratories — Product Code DGJ

K890689 is an FDA 510(k) premarket notification submitted by Abbott Laboratories for the device "ADX TM OPIATES". The FDA issued a decision of Substantially Equivalent on August 25, 1989. The device falls under product code DGJ (Colostrum, Antigen, Antiserum, Control), a Class I device regulated under 21 CFR 866.5230. Abbott Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 1989
Date Received
February 14, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Colostrum, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5230
Review Panel
IM
Submission Type

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FDA data resources