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510(k) K772114

FIAX C4 ASSAY by Idt, A Division of Whittaker M.A. Bioproducts — Product Code DAK

K772114 is an FDA 510(k) premarket notification submitted by Idt, A Division of Whittaker M.A. Bioproducts for the device "FIAX C4 ASSAY". The FDA issued a decision of Substantially Equivalent on November 30, 1977. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Idt, A Division of Whittaker M.A. Bioproducts has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 1977
Date Received
November 7, 1977
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 Idt, A Division of Whittaker M.A. Bioproducts

  • K853540 — FIAX TEST KIT FOR VARICELLA ANTIBODY SEROLOGY (February 4, 1986)
  • K853067 — FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (October 22, 1985)
  • K782041 — FIAX TEST KIT (January 3, 1979)
  • K772219 — FIAX TEST FOR ANTI-RUBELLA ANTIBODY (January 20, 1978)

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)
  • K972873 — IMMUSTRIP HAMA IGG (March 17, 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)

FDA data resources