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510(k) K970302

APO-TEK LP(A) by Perimmune, Inc. — Product Code DFC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1997
Date Received
January 27, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lipoprotein, Low-Density, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5600
Review Panel
IM
Submission Type

Other clearances by Perimmune, Inc.

  • K970353 — AURA TEK FDP (April 30, 1997)

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