VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)

Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization

ABBOTT MOLECULAR, INC.

The following data is part of a De Novo classification by Abbott Molecular, Inc. with the FDA for Vysis Egr1 Fish Probe Kit - Sc (specimen Characterization).

Pre-market Notification Details

• DeNovo ID: DEN130010
• Device Name: VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION)
• Classification: Early Growth Response Gene 1 (egr1) Fish Probe Kit For Specimen Characterization
• Applicant: ABBOTT MOLECULAR, INC. 1300 East Touhy Avenue Des Plaines, IL 60018
• Contact: Nancy W Bengtson
• Product Code: PDO
• CFR Regulation Number: 864.1870 [🔎]
• Decision: Granted (DENG)
• 510(k) Premarket Notification: K123951
• Review Advisory Board: Pathology
• Classification Advisory: Hematology
• Type: Post-NSE
• Date Received: 2013-04-09
• Decision Date: 2013-07-29
• FDA Review: Decision Summary
• Reclassification Order: Reclassification Order

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00884999038165	DEN130010	000