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510(k) K050713

DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 by Good Biotech Corp. — Product Code DCN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 2005
Date Received
March 18, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, C-Reactive Protein
Device Class
Class II
Regulation Number
866.5270
Review Panel
IM
Submission Type

Other clearances by Good Biotech Corp.

  • K063766 — TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105- (April 23, 2007)
  • K052617 — FERRITIN LIT ASSAY, CATALOG NO. 7010; FERRITIN CALIBRATOR SET, CATALOG NO. 7510; (February 23, 2006)
  • K050576 — MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H (April 21, 2005)
  • K022725 — CRPEX CRP CONTROLS LEVEL L, M, H; CAT. NO.: 3011, 3012, 3013 (September 23, 2002)
  • K021757 — CRPEX-BR C-REACTIVE PROTEIN LIT ASSAY, CRPEX-BR CRP CALIBRATOR SET (July 29, 2002)
  • K021882 — CRPEX-HS CRP CALIBRATOR SET, CATALOG NO: 1510 (July 11, 2002)
  • K020603 — CRPEX-HS C-REACTIVE PROTEIN LIT ASSAY, CATALOG NO. 1010 (June 13, 2002)

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