BIOTRACK ALT TEST CARTRIDGE— 510(k) K895128

Substantially Equivalent

Biotrack, Inc.

FDA 510(k) clearance K895128 for BIOTRACK ALT TEST CARTRIDGE, Substantially Equivalent on 1989-10-06. Applicant: Biotrack, Inc.. Device class: 1.

Clearance details

Applicant: Biotrack, Inc.
Product code: Code CJJ
Device class: Class 1
Regulation: 21 CFR 862.1030
Advisory panel: Clinical Chemistry
Date received: 1989-08-17
Decision date: 1989-10-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJJ

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K920525 — BIOTRACK THERAPEUTIC DRUG MONITORING QUAL. CONTROL1992-08-05
K915755 — BIOTRACK PHENYTOIN TEST CARTRIDGE1992-07-23
K915756 — BIOTRACK CARBAMAZEPINE TEST CARTRIDGE1992-07-23

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