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510(k) K841541

SERUM COMPLEMENT ACTIVITY TEST-SCAT by Collaborative Research, Inc. — Product Code DAK

K841541 is an FDA 510(k) premarket notification submitted by Collaborative Research, Inc. for the device "SERUM COMPLEMENT ACTIVITY TEST-SCAT". The FDA issued a decision of Substantially Equivalent on June 1, 1984. The device falls under product code DAK (Complement C1q, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Collaborative Research, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 1984
Date Received
April 16, 1984
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 Collaborative Research, Inc.

  • K840241 — THYROXINE EMIA (March 30, 1984)

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