Home / 510(k) Clearances / K861362

510(k) K861362

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

K861362 is an FDA 510(k) premarket notification submitted by Immunomedics, Inc. for the device "IMMUNOMEDICS SERUM ELISA TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on June 6, 1986. The device falls under product code CZW (Complement C3, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Immunomedics, Inc. has at least 3 other 510(k) clearances on record.

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.

  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K873741 — IMMUSTRIP(TM) SM ELISA TEST SYSTEM (November 4, 1987)
  • K870903 — IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (May 14, 1987)

Other clearances for product code CZW

  • K100179 — SPAPLUS (August 13, 2010)
  • K063150 — COMPLEMENT C3 AND C4, SPECICAL CALIBRATOR AND SPECITROL CONTROL AND HIGH CONTROL (March 19, 2007)
  • K061852 — DIMENSION VISTA C3 AND C4 FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, CONTROL (September 22, 2006)
  • 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)
  • K032796 — IBL C3D-CIC EIA TEST (January 13, 2004)
  • 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)

FDA data resources