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510(k) K891299

MID-LEVEL IGG KIT CAT. NO. 9315 by Helena Laboratories — Product Code DAQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1989
Date Received
March 13, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igg (Fd Fragment Specific), Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5540
Review Panel
IM
Submission Type

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