IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS)— 510(k) K012301

Name: FDA 510(k) clearance K012301
Creator: U.S. Food and Drug Administration
Published: 2001-09-19

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K012301 for IMMULITE 2000 DIGOXIN, MODELS L2KDI2 (200 TESTS) AND L2KDI6 (600 TESTS), Substantially Equivalent on 2001-09-19. Applicant: Diagnostic Products Corp.. Device class: 2.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code KXT
Device class: Class 2
Regulation: 21 CFR 862.3320
Advisory panel: Clinical Toxicology
Date received: 2001-07-20
Decision date: 2001-09-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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