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510(k) K801363

COMPLEMENT C3 NEPHELOMETRIC ASSAY by J.T. Baker Chemical Co. — Product Code CZW

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 C3, 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)
  • K801669 — J.T. BAKER ALPHA-1-ANTITRYPSIN NEPHELO (September 16, 1980)
  • K801795 — BAKER DIAGNOSTIC ULTRA-RATE SODIUM/POT. (September 16, 1980)
  • K801661 — J.T. BAKER CERULOPLASMIN NEPHELOMETRIC (September 16, 1980)
  • K801362 — ALBUMIN NEPHELOMETRIC ASSAY (July 21, 1980)
  • K801434 — J.T. BAKER TRANSFERRIN NEPHELOMETRIC ASS (July 8, 1980)

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