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510(k) K855191

TOTAL PROTEIN REAGENT SET by Technostics Intl. — Product Code CEK

K855191 is an FDA 510(k) premarket notification submitted by Technostics Intl. for the device "TOTAL PROTEIN REAGENT SET". The FDA issued a decision of Substantially Equivalent on January 14, 1986. The device falls under product code CEK (Biuret (Colorimetric), Total Protein), a Class II device regulated under 21 CFR 862.1635. Technostics Intl. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1986
Date Received
December 26, 1985
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 Technostics Intl.

  • K855188 — CPK (UV) REAGENT KIT (March 5, 1986)
  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K855190 — MAGNESIUM REAGENT SET (February 18, 1986)
  • K860110 — GLUTAMIC PYRUVIC TRANSAMINASE, GPT(UV) REAGENT SET (February 11, 1986)
  • K860109 — ENZYMATIC UREA NITROGEN REAGENT SET (February 6, 1986)
  • K860112 — TOTAL LIPIDS REAGENT SET (January 24, 1986)
  • K855185 — GLUCOSE REAGENT SET (January 22, 1986)
  • K855157 — LACTIC DEHYDROGENASE (VV) REAGENT SET (January 21, 1986)
  • K855154 — INORGANIC PHOSPHORUS REAGENT SET (January 14, 1986)
  • K855193 — CREATININE REAGENT SET (January 14, 1986)

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