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510(k) K072638

ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 by Roche Diagnostics Corp. — Product Code JGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2007
Date Received
September 18, 2007
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Turbidimetric, Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

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Other clearances for product code JGQ

  • K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (June 7, 2013)
  • K071239 — TOTAL PROTEIN URINE/CSF GEN.3 (September 14, 2007)
  • K981295 — UPRO (October 1, 1998)
  • K981682 — UPRO (September 21, 1998)
  • K925794 — TRACE MICROPROTEIN REAGENT (March 29, 1993)
  • K913615 — URINARY/CSF PROTEIN (September 13, 1991)
  • K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (October 3, 1990)
  • K901083 — EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (April 16, 1990)
  • K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (October 29, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)