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
00888937028980	K173624	000
00888937028973	K173624	000
00888937028966	K173624	000
00888937028959	K173624	000