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510(k) K972873

IMMUSTRIP HAMA IGG by Immunomedics, Inc. — Product Code DAK

K972873 is an FDA 510(k) premarket notification submitted by Immunomedics, Inc. for the device "IMMUSTRIP HAMA IGG". The FDA issued a decision of Substantially Equivalent on March 17, 1998. The device falls under product code DAK (Complement C1q, 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
March 17, 1998
Date Received
August 4, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C1q, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

Other clearances by Immunomedics, Inc.

  • K873741 — IMMUSTRIP(TM) SM ELISA TEST SYSTEM (November 4, 1987)
  • K870903 — IMMUSTRIP(TM) DSDNA ELISA TEST SYSTEM (May 14, 1987)
  • K861362 — IMMUNOMEDICS SERUM ELISA TEST SYSTEM (June 6, 1986)

Other clearances for product code DAK

  • K031563 — BINDAZYME CLQ CIC EIA KIT (September 10, 2003)
  • K032254 — IBL C1Q-CIC CIA TEST (August 29, 2003)
  • K012576 — CIC-C1Q EIA (January 29, 2002)
  • K973203 — THYMOSTAT ELISA FOR THE DETECTION OF HUMAN IGG,M AND A ANTI-RABBIT IGG ANTIBODI (September 30, 1998)
  • K951968 — HUMAN C1Q RADIAL IMMUNODIFFUSION KIT (May 30, 1995)
  • K914388 — C1 RID KIT (October 28, 1991)
  • K882829 — CIRCULATING IMMUNE COMPLEXES CONTROLS (August 4, 1988)
  • K860996 — SANASSAY IC TEST (March 30, 1987)
  • K864312 — IC MICROASSAY (January 9, 1987)
  • K862649 — CYTOTECH CIC ENZYME IMMUNOASSAY (September 4, 1986)

FDA data resources