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510(k) K903914

PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK by Baxter Healthcare Corp — Product Code JGQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1990
Date Received
August 24, 1990
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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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)
  • K925794 — TRACE MICROPROTEIN REAGENT (March 29, 1993)
  • K913615 — URINARY/CSF PROTEIN (September 13, 1991)
  • 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)