CSF/URINE TOTAL PROTEIN— 510(k) K961864

Substantially Equivalent

Teco Diagnostics

FDA 510(k) clearance K961864 for CSF/URINE TOTAL PROTEIN, Substantially Equivalent on 1996-10-24. Applicant: Teco Diagnostics. Device class: 2.

Clearance details

Applicant: Teco Diagnostics
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1996-05-14
Decision date: 1996-10-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Placentia, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

K992846 — HICHEM TOTAL PROTEIN REAGENT1999-10-18
K973108 — TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-501998-03-02
K980042 — CARESIDE TOTAL PROTEIN1998-02-04
K971524 — TOTAL PROTEIN OR TP1997-05-16
K955905 — STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY1996-05-30

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K131600 — URS-2GP (GLUCOSE PROTEIN) URINE STRIPS2014-05-29
K111206 — TECO DIAGNOSTICS SALIVA ALCOHOL TEST2011-10-04
K100024 — TECO DIAGNOSTICS UTI DETECTION STRIPS2011-02-17

Data sourced from openFDA. This site is unofficial and independent of the FDA.