SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS

Media, Reproductive

ORIGIO A/S

The following data is part of a premarket notification filed by Origio A/s with the FDA for Sage 1-step With Human Serum Albumin, Sage 1-step With Serum Protein Supplements.

Pre-market Notification Details

• Device ID: K133707
• 510k Number: K133707
• Device Name: SAGE 1-STEP WITH HUMAN SERUM ALBUMIN, SAGE 1-STEP WITH SERUM PROTEIN SUPPLEMENTS
• Classification: Media, Reproductive
• Applicant: ORIGIO A/S Knardrupvej 2 Maaloev, DK 2760
• Contact: Tove Kjaer
• Correspondent: Tove Kjaer; ORIGIO A/S Knardrupvej 2 Maaloev, DK 2760
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2013-12-04
• Decision Date: 2014-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888937803402	K133707	000
00888937803389	K133707	000
00888937803365	K133707	000
00888937803341	K133707	000