ISOLAB'S T4 TEST KIT— 510(k) K951014

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K951014 for ISOLAB'S T4 TEST KIT, Substantially Equivalent on 1996-10-18. Applicant: Isolab, Inc.. Device class: 2.

Clearance details

Applicant: Isolab, Inc.
Product code: Code KLI
Device class: Class 2
Regulation: 21 CFR 862.1700
Advisory panel: Clinical Chemistry
Date received: 1995-03-06
Decision date: 1996-10-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

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More clearances from Isolab, Inc.

K950481 — NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT1996-02-01
K943547 — PHENYLALANINE TEST KIT1996-01-26
K950803 — ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE1995-09-21
K950415 — FLUOROSCAN NEONATAL1995-09-05
K942222 — QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS1995-01-20

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