CIBA CORNING CERTAIN LYTE— 510(k) K894576

Name: FDA 510(k) clearance K894576
Creator: U.S. Food and Drug Administration
Published: 1989-10-30

Substantially Equivalent

Ciba Corning Diagnostics Corp.

FDA 510(k) clearance K894576 for CIBA CORNING CERTAIN LYTE, Substantially Equivalent on 1989-10-30. Applicant: Ciba Corning Diagnostics Corp.. Device class: 1.

Clearance details

Applicant: Ciba Corning Diagnostics Corp.
Product code: Code JJR
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 1989-07-21
Decision date: 1989-10-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: East Walpole, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JJR

view all

K990971 — EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 28161999-04-27
K960592 — ELECTROLYTE STANDARDS1996-05-13
K955630 — RNA MEDICAL HEMAT CONTROL1996-03-01
K951435 — AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL1995-05-02
K943925 — SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING1994-10-04

More clearances from Ciba Corning Diagnostics Corp.

view all

K962559 — ACS CORTISOL IMMUNOASSAY1996-11-05
K963251 — CIBA CORNING ACS; 180 DPD ASSAY1996-10-15
K961807 — CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 41996-07-26
K961657 — CIBA CORNING 400 SYSTEM1996-06-25
K962021 — CIBA CORNING 348 SYSTEM1996-06-24

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