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510(k) K861362

IMMUNOMEDICS SERUM ELISA TEST SYSTEM by Immunomedics, Inc. — Product Code CZW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1986
Date Received
April 10, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Immunomedics, Inc.

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  • K873741 — IMMUSTRIP(TM) SM ELISA TEST SYSTEM (November 4, 1987)
  • K870903 — IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (May 14, 1987)

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  • K050665 — N ANTISERA TO HUMAN COMPLEMENT FACTORS (C3C, C4) (May 2, 2005)
  • K042494 — VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMA (October 19, 2004)
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  • K032035 — SYNCHRON LX SYSTEMS COMPLEMENT C3 (C3) REAGENT, SYNCHRON LX SYSTEMS COMPLEMENT C (August 7, 2003)
  • K012361 — TINA-QUANT COMPLEMENT C3C TEST SYSTEM (November 29, 2001)
  • K010326 — WAKO AUTOKIT C3 (June 25, 2001)
  • K000469 — RANDOX COMPLEMENT C3 (March 27, 2000)