ORIGIO® Handling™ Without Phenol Red (Cat. No. 8310), ORIGIO® Handling™ With Phenol Red (Cat. No. 8311)

Media, Reproductive

Origio A/s

The following data is part of a premarket notification filed by Origio A/s with the FDA for Origio® Handling™ Without Phenol Red (cat. No. 8310), Origio® Handling™ With Phenol Red (cat. No. 8311).

Pre-market Notification Details

• Device ID: K173624
• 510k Number: K173624
• Device Name: ORIGIO® Handling™ Without Phenol Red (Cat. No. 8310), ORIGIO® Handling™ With Phenol Red (Cat. No. 8311)
• Classification: Media, Reproductive
• Applicant: Origio A/s Knardrupvej 2 Malov, DK 2760
• Contact: Tove Kjaer
• Correspondent: Tove Kjaer; Origio A/s Knardrupvej 2 2760 Måløv, DK
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-11-24
• Decision Date: 2018-03-02
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888937835489	K173624	000
00888937835472	K173624	000
00888937835465	K173624	000
00888937835458	K173624	000