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510(k) K801361

COMPLEMENT C4 NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co. — Product Code DBI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 30, 1980
Date Received
June 9, 1980
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

Other clearances by J.T. Baker Chemical Co.

  • K803128 — SERIES 810 PLATELET ANALYZER (April 3, 1981)
  • K802080 — BAKER DIAG. ULTRARATE CHLORIDE KIT (October 10, 1980)
  • K802035 — BAKER DIAG. ULTRARATE CO2 REAGENT KIT (September 26, 1980)
  • K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRIC (September 26, 1980)
  • K801662 — J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (July 8, 1980)

Other clearances for product code DBI

  • K100455 — SPAPLUS ANALYZER (September 3, 2010)
  • K012359 — TINA-QUANT COMPLEMENT C4 TEST SYSTEM (November 29, 2001)
  • 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)
  • K964300 — N-ASSAY TIA MULTI V-NL (July 14, 1997)
  • K964297 — N-ASSAY TIA C4 TEST KIT (July 14, 1997)