VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020

Early Growth Response 1 (egr) Fish Probe Kit

ABBOTT MOLECULAR, INC.

The following data is part of a premarket notification filed by Abbott Molecular, Inc. with the FDA for Vysis Egr1 Fish Probe Kit (vysis Lsi Egr1 Spectrum/orange/d5s23, D5s721, Spectrum Green Probe), Model 4n37-020.

Pre-market Notification Details

• Device ID: K091960
• 510k Number: K091960
• Device Name: VYSIS EGR1 FISH PROBE KIT (VYSIS LSI EGR1 SPECTRUM/ORANGE/D5S23, D5S721, SPECTRUM GREEN PROBE), MODEL 4N37-020
• Classification: Early Growth Response 1 (egr) Fish Probe Kit
• Applicant: ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018
• Contact: Pamela L Swatkowski
• Correspondent: Pamela L Swatkowski; ABBOTT MOLECULAR, INC. 1300 EAST TOUHY AVENUE Des Plaines, IL 60018
• Product Code: OWK
• CFR Regulation Number: 866.6040 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-07-01
• Decision Date: 2011-08-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884999008366	K091960	000