EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95— 510(k) K864926

Name: FDA 510(k) clearance K864926
Creator: U.S. Food and Drug Administration
Published: 1987-01-07

Substantially Equivalent

Em Diagnostic Systems, Inc.

FDA 510(k) clearance K864926 for EMDS TM PHENOBARBITAL(PHNO) TESTPACK, #67677/95, Substantially Equivalent on 1987-01-07. Applicant: Em Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Em Diagnostic Systems, Inc.
Product code: Code DLZ
Device class: Class 2
Regulation: 21 CFR 862.3660
Advisory panel: Clinical Toxicology
Date received: 1986-12-16
Decision date: 1987-01-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Gibbstown, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DLZ

view all

K210858 — VITROS Chemistry Products PHBR Slides2021-08-13
K123271 — ABBOTT PHENOBARBITAL ASSAY2013-04-26
K081231 — ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P332008-09-26
K071644 — ONLINE PHENOBARBITAL, MODEL 03016757190 & 035106202007-09-12
K011303 — RANDOX PHENOBARBITAL2001-07-02

More clearances from Em Diagnostic Systems, Inc.

view all

K935181 — ASPARTATE AMINOTRANSFERASE (AST) TEST1994-01-27
K935180 — ALANINE AMINOTRANSFERASE (ALT) TEST1994-01-13
K935178 — EMDS PHOSPHOROUS (PHOS) TEST1993-12-17
K935179 — EMDS ALBUMIN (ALB) TEST1993-12-17
K935136 — CHOLESTEROL (CHOL) TEST ITEM NO. 654101993-12-16

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