QMS PHENOBARBITAL— 510(k) K934388

Substantially Equivalent

Seradyn, Inc.

FDA 510(k) clearance K934388 for QMS PHENOBARBITAL, Substantially Equivalent on 1994-02-25. Applicant: Seradyn, Inc.. Device class: 2.

Clearance details

Applicant: Seradyn, Inc.
Product code: Code LFN
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1993-09-09
Decision date: 1994-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Indianapolis, IN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LFN

K864612 — DART PHENOBARBITAL ASSAY SYSTEM1987-01-13
K860303 — DUPONT PHENOBARBITAL CALIBRATOR1986-02-28
K860304 — DUPONT PHENOBARBITAL ASSAY1986-02-28
K821543 — IPA FOR DETECTION OF PHENOBARBITAL1982-06-03

More clearances from Seradyn, Inc.

K070645 — SERADYN QMS TOPIRAMATE2007-05-17
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K062204 — ARCHITECT CORTISOL ASSAY2006-09-22
K060998 — QMS TOBRAMYCIN2006-07-21
K060709 — MULTIGENT GENTAMICIN2006-06-15

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