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510(k) K862087

SANTEST 1AP by Scientific Sales Intl., Inc. — Product Code LKL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1986
Date Received
June 2, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control
Device Class
Class I
Regulation Number
866.5420
Review Panel
IM
Submission Type

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  • K873868 — ALPHA-1-ACID GLYCOPROTEIN (OROSOMUCOID) (October 20, 1987)
  • K861336 — IAP PLATE TEST (April 25, 1986)
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