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510(k) K941496

SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY by Solarcare, Inc. — Product Code CEK

K941496 is an FDA 510(k) premarket notification submitted by Solarcare, Inc. for the device "SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAY". The FDA issued a decision of Substantially Equivalent on October 27, 1994. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Solarcare, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1994
Date Received
March 28, 1994
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, Inc.

  • K934775 — STC COCAINE METABOLITE EIA (July 14, 1995)
  • K944372 — STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA (February 8, 1995)
  • K941497 — SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAY (May 24, 1994)
  • K934376 — STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIA (December 7, 1993)
  • K933327 — HISTOFREEZER (October 29, 1993)

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)
  • K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY (May 30, 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)

FDA data resources