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510(k) K982350

EA-D IGM ELISA TEST SYSTEM by Columbia Bioscience, Inc. — Product Code LSE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 25, 1998
Date Received
July 6, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Epstein-Barr Virus, Other
Device Class
Class I
Regulation Number
866.3235
Review Panel
MI
Submission Type

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  • K983553 — ANTI-TG IGG ELISA TEST SYSTEM (December 7, 1998)
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  • K983740 — IS-ANTI-PR3 IGG ELISA TEST SYSTEM (November 18, 1998)
  • K983390 — IS-ANTI-MPO IGG ELISA TEST SYSTEM (November 18, 1998)

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