ISOSCAN— 510(k) K944185

Substantially Equivalent

Isolab, Inc.

FDA 510(k) clearance K944185 for ISOSCAN, Substantially Equivalent on 1994-11-17. Applicant: Isolab, Inc.. Device class: 1.

Clearance details

Applicant: Isolab, Inc.
Product code: Code JQT
Device class: Class 1
Regulation: 21 CFR 862.2400
Advisory panel: Clinical Chemistry
Date received: 1994-08-26
Decision date: 1994-11-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Akron, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JQT

K111356 — ASIMANAGER - AT2011-11-09
K915332 — MODEL 795 FLUOROMETER/DENSITOMETER1992-02-18
K885254 — TARGET READER1989-01-27
K860645 — ELECTROPHORESIS DATA CENTER (EDC)1986-12-17
K862956 — ICON READER1986-08-19

More clearances from Isolab, Inc.

K951014 — ISOLAB'S T4 TEST KIT1996-10-18
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

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