VENTREZYME THEOPHYLLINE IMMUNOASSAY— 510(k) K833989

Substantially Equivalent

Vxr, Inc.

FDA 510(k) clearance K833989 for VENTREZYME THEOPHYLLINE IMMUNOASSAY, Substantially Equivalent on 1984-01-30. Applicant: Vxr, Inc.. Device class: 2.

Clearance details

Applicant: Vxr, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1983-11-18
Decision date: 1984-01-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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More clearances from Vxr, Inc.

K853703 — VENTREZYME T3 IMMUNOASSAY T31985-10-04
K853748 — VENTRESCREEN HCG URINE1985-10-01
K841456 — VENTREXYME EIA CONTROLS IMMUNOASSAY1984-05-21
K840473 — VENTREZYME T4 IMMUNOASSAY T41984-04-04
K833960 — VENTREX PREGNANCY TEST KIT ENZYME1984-02-03

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