CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER— 510(k) K993375

Name: FDA 510(k) clearance K993375
Creator: U.S. Food and Drug Administration
Published: 1999-12-20

Substantially Equivalent

Clinical Diagnostic Solutions, Inc.

FDA 510(k) clearance K993375 for CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER, Substantially Equivalent on 1999-12-20. Applicant: Clinical Diagnostic Solutions, Inc.. Device class: 2.

Clearance details

Applicant: Clinical Diagnostic Solutions, Inc.
Product code: Code KRX
Device class: Class 2
Regulation: 21 CFR 864.8150
Advisory panel: Hematology
Date received: 1999-10-07
Decision date: 1999-12-20
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Plantation, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRX

view all

K160585 — XN CAL2016-12-22
K141955 — XN CAL PF2014-12-05
K141962 — XN CAL2014-12-05
K120747 — XN CAL PF2012-10-22
K120745 — XN CAL2012-10-19

Clearance details

Recent devices under product code KRX

More clearances from Clinical Diagnostic Solutions, Inc.