Home / 510(k) Clearances / K050576

510(k) K050576

MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H by Good Biotech Corp. — Product Code DDZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2005
Date Received
March 7, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Albumin, Fitc, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5040
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)
  • K050713 — DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALO (June 6, 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)

Other clearances for product code DDZ

  • K023860 — MICROALBUMIN REAGENT SET AND CALIBRATORS (April 28, 2003)
  • K002674 — RANDOX MICROALBUMIN (October 5, 2000)
  • K831902 — FLUORESCEIN CONJUGATED IMMUNOGLOBIN- (July 18, 1983)