PROTEIN ASSAY KIT— 510(k) K790808

Name: FDA 510(k) clearance K790808
Creator: U.S. Food and Drug Administration
Published: 1979-11-05

Substantially Equivalent

Specialty Medical Industries, Inc.

FDA 510(k) clearance K790808 for PROTEIN ASSAY KIT, Substantially Equivalent on 1979-11-05. Applicant: Specialty Medical Industries, Inc.. Device class: 2.

Clearance details

Applicant: Specialty Medical Industries, Inc.
Product code: Code CEK
Device class: Class 2
Regulation: 21 CFR 862.1635
Advisory panel: Clinical Chemistry
Date received: 1979-04-26
Decision date: 1979-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEK

view all

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 Specialty Medical Industries, Inc.

view all

K872968 — ULTRASCAN IGE ASSAY KIT1987-08-28
K862999 — ULTRASCAN CLINICAL ANALYZER1986-09-15

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