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510(k) K955905

STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY by Solarcare Technologies Corp,Inc. — Product Code CEK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 30, 1996
Date Received
December 29, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biuret (Colorimetric), Total Protein
Device Class
Class II
Regulation Number
862.1635
Review Panel
CH
Submission Type

Other clearances by Solarcare Technologies Corp,Inc.

  • K954326 — STC DIAGNOSTICS AUTO-LYTE URINARY HEMOGLOBIN ASSAY (July 23, 1996)
  • K954156 — STC DIAGNOSTICS AUTO-LYTE URINARY LEUKOCYTE ESTERASE ASSAY (July 22, 1996)
  • K954158 — STC DIAGNOSTICS AUTO-LYTE PH ASSAY (April 30, 1996)
  • K940048 — STC DIAGNOSTICS PCP MICRO-PLATE EIA MODIFICATION (March 19, 1996)
  • K954073 — STC DIAGNOSTICS LSD MICRO-PLATE EIA (November 29, 1995)
  • K954266 — STC DIAGNOSTICS AUTO-LYTE CREATININE ASSAY (October 13, 1995)
  • K935573 — AMPHETAMINES MICRO-PLATE EIA (July 14, 1995)
  • K935565 — OPIATES MICRO-PLATE ASSAY (July 14, 1995)
  • K950308 — STC DIAGNOSTICS AUTO-LYTE(R) METHAQUALONE EIA (April 14, 1995)
  • K944056 — AUTO-LYTE METHADONE DIA (December 29, 1994)

Other clearances for product code CEK

  • K992846 — HICHEM TOTAL PROTEIN REAGENT (October 18, 1999)
  • K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50 (March 2, 1998)
  • K980042 — CARESIDE TOTAL PROTEIN (February 4, 1998)
  • K971524 — TOTAL PROTEIN OR TP (May 16, 1997)
  • K961864 — CSF/URINE TOTAL PROTEIN (October 24, 1996)
  • K955936 — TOTAL PROTEIN REAGENT (March 12, 1996)
  • K950920 — DUPONT DIMENSION TOTAL PROTEIN METHOD (August 11, 1995)
  • K950234 — TOTAL PROTEIN TEST (TPRO) ITEM NUMBER: XXXXX/R1. R2 (June 14, 1995)
  • K950128 — TOTAL PROTEIN TEST (TPRO) ITEM XXXXX/R1. R2 (May 15, 1995)
  • K943004 — TOTAL PROTEIN QVET (December 9, 1994)