ACCUMETER THEOPHYLLINE TEST— 510(k) K972495

Substantially Equivalent

Chemtrak, Inc.

FDA 510(k) clearance K972495 for ACCUMETER THEOPHYLLINE TEST, Substantially Equivalent on 1997-10-10. Applicant: Chemtrak, Inc.. Device class: 2.

Clearance details

Applicant: Chemtrak, Inc.
Product code: Code KLS
Device class: Class 2
Regulation: 21 CFR 862.3880
Advisory panel: Clinical Toxicology
Date received: 1997-07-03
Decision date: 1997-10-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLS

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More clearances from Chemtrak, Inc.

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K943279 — ACCUMETER HDL CHOLESTEROL TEST1995-05-01
K943599 — CHEM TRAK ACCUMETER1995-03-21
K914432 — ACCUMETER(R) CHOLESTEROL SELF-TEST1993-03-02

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