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510(k) K901083

EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 by Em Diagnostic Systems, Inc. — Product Code JGQ

K901083 is an FDA 510(k) premarket notification submitted by Em Diagnostic Systems, Inc. for the device "EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95". The FDA issued a decision of Substantially Equivalent on April 16, 1990. The device falls under product code JGQ (Turbidimetric, Total Protein), a Class II device regulated under 21 CFR 862.1635. Em Diagnostic Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 16, 1990
Date Received
March 7, 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

Other clearances by Em Diagnostic Systems, Inc.

  • K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST (January 27, 1994)
  • K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST (January 13, 1994)
  • K935178 — EMDS PHOSPHOROUS (PHOS) TEST (December 17, 1993)
  • K935179 — EMDS ALBUMIN (ALB) TEST (December 17, 1993)
  • K935175 — LACTATE DEHYDROGENASE (LD) (December 16, 1993)
  • K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 65410 (December 16, 1993)
  • K935176 — IRON TEST (December 16, 1993)
  • K935177 — GAMMA-GLUTAMYL TRANSFERASE (GGT) TEST (December 16, 1993)
  • K935174 — TOTAL PROTEIN TEST (TPRO) (December 16, 1993)
  • K935183 — EMDS MAGNESIUM (MG) TEST (December 9, 1993)

Other clearances for product code JGQ

  • K131051 — HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (June 7, 2013)
  • 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)
  • K903914 — PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK (October 3, 1990)
  • K863478 — CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (October 29, 1986)
  • K842134 — SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (July 6, 1984)

FDA data resources