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510(k) K925794

TRACE MICROPROTEIN REAGENT by Trace America, Inc. — Product Code JGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 29, 1993
Date Received
November 16, 1992
Clearance Type
Traditional
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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  • K971477 — UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST) (May 27, 1997)
  • K971485 — URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DST) (May 27, 1997)
  • K962723 — TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN (March 13, 1997)

Other clearances for product code JGQ

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  • K072638 — ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (October 19, 2007)
  • K071239 — TOTAL PROTEIN URINE/CSF GEN.3 (September 14, 2007)
  • K981295 — UPRO (October 1, 1998)
  • K981682 — UPRO (September 21, 1998)
  • 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)