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510(k) K873741

IMMUSTRIP(TM) SM ELISA TEST SYSTEM by Immunomedics, Inc. — Product Code LKP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
September 16, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Anti-Sm Antibody, Antigen And Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Immunomedics, Inc.

  • K972873 — IMMUSTRIP HAMA IGG (March 17, 1998)
  • K870903 — IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (May 14, 1987)
  • K861362 — IMMUNOMEDICS SERUM ELISA TEST SYSTEM (June 6, 1986)

Other clearances for product code LKP

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  • K183007 — EliA SmDP Immunoassay (December 24, 2018)
  • K132631 — EIA SMDP IMMUNOASSAY (August 29, 2014)
  • K123593 — QUANTA FLASH SM, QUANTA FLASH RNP, QUANTA FLASH SM CALIBRATORS, QUANTA FLASH RNP (April 17, 2013)
  • K051066 — THERATEST EL-ANA PROFILES (October 7, 2005)
  • K042629 — VARELISA SM ANTIBODIES, MODEL 18296 (December 8, 2004)
  • K024219 — LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 (January 15, 2003)
  • K013263 — FRED HUTCHINSON CANCER RESEARCH CENTER ENZYME ANTI-SR PROTEIN ANTIBODY TEST (July 29, 2002)
  • K000755 — RHIGENE MESACUP2 TEST- SM (May 9, 2000)
  • K000312 — VARELISA SM ANTIBODIES (March 17, 2000)