TOTAL PROTEIN TEST— 510(k) K811673

Substantially Equivalent

King Diagnostics, Inc.

FDA 510(k) clearance K811673 for TOTAL PROTEIN TEST, Substantially Equivalent on 1981-06-25. Applicant: King Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: King Diagnostics, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1981-06-15
Decision date: 1981-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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
K961864 — CSF/URINE TOTAL PROTEIN1996-10-24

More clearances from King Diagnostics, Inc.

K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT1993-10-22
K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED1993-08-25
K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE)1993-08-16
K931326 — KING DIAGNOSTICS CK REAGENT1993-06-15
K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT1992-11-02

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