MULTIPURPOSE HANDLING MEDIUM

Media, Reproductive

IRVINE SCIENTIFIC SALES CO., INC.

The following data is part of a premarket notification filed by Irvine Scientific Sales Co., Inc. with the FDA for Multipurpose Handling Medium.

Pre-market Notification Details

• Device ID: K121128
• 510k Number: K121128
• Device Name: MULTIPURPOSE HANDLING MEDIUM
• Classification: Media, Reproductive
• Applicant: IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST Santa Ana, CA 92705
• Contact: Jayme Yamaguchi-owens
• Correspondent: Jayme Yamaguchi-owens; IRVINE SCIENTIFIC SALES CO., INC. 2511 DAIMLER ST Santa Ana, CA 92705
• Product Code: MQL
• CFR Regulation Number: 884.6180 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: Yes
• Date Received: 2012-04-13
• Decision Date: 2012-06-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00857515006276	K121128	000