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510(k) K012359

TINA-QUANT COMPLEMENT C4 TEST SYSTEM by Roche Diagnostics Corp. — Product Code DBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 29, 2001
Date Received
July 25, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C4, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
Submission Type

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Other clearances for product code DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K010325 — WAKO AUTOKIT C4 (June 25, 2001)
  • K000468 — RANDOX COMPLEMENT C4 (March 27, 2000)
  • K994293 — DIMENSION C4 FLEX REAGENT CARTRIDGE (March 1, 2000)
  • K981785 — C4 MININEPH ANTISERUM (December 20, 1999)
  • K993481 — K-ASSAY C4 (November 29, 1999)
  • K983356 — C4 (November 4, 1998)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K962582 — OLYMPUS C4 IMMUNOTURBIDIMETRIC REAGENT (October 18, 1996)