ROTOR

Analyzer, Chemistry, Centrifugal, For Clinical Use

AMERICAN SCIENTIFIC PRODUCTS

The following data is part of a premarket notification filed by American Scientific Products with the FDA for Rotor.

Pre-market Notification Details

• Device ID: K831571
• 510k Number: K831571
• Device Name: ROTOR
• Classification: Analyzer, Chemistry, Centrifugal, For Clinical Use
• Applicant: AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JJG
• CFR Regulation Number: 862.2140 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-05-16
• Decision Date: 1983-06-30