ACCLAIM

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

ELECTRO-NUCLEONICS LABORATORIES, INC.

The following data is part of a premarket notification filed by Electro-nucleonics Laboratories, Inc. with the FDA for Acclaim.

Pre-market Notification Details

• Device ID: K832648
• 510k Number: K832648
• Device Name: ACCLAIM
• Classification: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
• Applicant: ELECTRO-NUCLEONICS LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534
• Product Code: JJE
• CFR Regulation Number: 862.2160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-08-05
• Decision Date: 1983-09-20