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Refractometer For Donor Testing

Reichert Inc.

The following data is part of a premarket notification filed by Reichert Inc. with the FDA for 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.s. Food & Drug Administration   Follow Fda En Español Search Fda   Home Food Drugs Medical Devices .

Pre-market Notification Details

• Device ID: BK170128
• 510k Number: BK170128
• Device Name: 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
• Classification: Refractometer For Donor Testing
• Applicant: Reichert Inc. 3362 Walden Ave suite 100 Depew, NY 14043 US
• Product Code: PSM
• CFR Regulation Number: 862.2800 [🔎]
• Decision: Substantially Equivalent (SE)
• Type: 510(k) Traditio
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2017-10-02
• Decision Date: 2017-12-19

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00812559012522	BK170128	0