BCS POTASSIUM TURBIDIMETRIC TEST— 510(k) K850258

Name: FDA 510(k) clearance K850258
Creator: U.S. Food and Drug Administration
Published: 1985-02-07

Substantially Equivalent

Bioclinical Systems, Inc.

FDA 510(k) clearance K850258 for BCS POTASSIUM TURBIDIMETRIC TEST, Substantially Equivalent on 1985-02-07. Applicant: Bioclinical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Bioclinical Systems, Inc.
Product code: Code CEJ
Device class: Class 2
Regulation: 21 CFR 862.1600
Advisory panel: Clinical Chemistry
Date received: 1985-01-22
Decision date: 1985-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St.Louis, MO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CEJ

view all

K043267 — POTASSIUM TEST KIT AND ELECTROLYTE CAL 1 AND 22005-02-10
K943026 — POTASSIUM QVET1994-12-09
K904033 — REFLOTRON POTASSIUM TEST TABS1990-11-06
K902574 — POTASSIUM REAGENT SET1990-07-10
K883585 — TECHNICON ASSIST POTASSIUM1988-11-29

More clearances from Bioclinical Systems, Inc.

view all

K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA1995-06-30
K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS1995-04-04
K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR1994-02-09
K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR1994-02-03
K873086 — ROUND 11987-08-24

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