QMS(TM) - THEOPHYLLINE— 510(k) K885263

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K885263 for QMS(TM) - THEOPHYLLINE, Substantially Equivalent on 1989-03-28. Applicant: Seradyn, Inc.. Device class: 1.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code JQX
Device class: Class 1
Regulation: 21 CFR 862.2700
Advisory panel: Clinical Chemistry
Date received: 1988-12-23
Decision date: 1989-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

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