TENONE(TM) OPIATES CATALOG: VKSO1,4— 510(k) K902055

Name: FDA 510(k) clearance K902055
Creator: U.S. Food and Drug Administration
Published: 1990-07-10

Substantially Equivalent

Diagnostic Products Corp.

FDA 510(k) clearance K902055 for TENONE(TM) OPIATES CATALOG: VKSO1,4, Substantially Equivalent on 1990-07-10. Applicant: Diagnostic Products Corp.. Device class: 1.

Clearance details

Applicant: Diagnostic Products Corp.
Product code: Code DDE
Device class: Class 1
Regulation: 21 CFR 866.5200
Advisory panel: Immunology
Date received: 1990-05-07
Decision date: 1990-07-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDE

view all

K823680 — COAT-A-COUNT MORPHINE KIT & COMPONENTS1983-01-05
K820900 — EMIT URINE METHADONE ASSAY #3E3191982-04-26

More clearances from Diagnostic Products Corp.

view all

K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN2006-12-05
K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I2004-01-21
K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER2003-12-12
K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE2003-10-10
K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE2002-12-17

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