PRISMA

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

LKB INSTRUMENTS, INC.

The following data is part of a premarket notification filed by Lkb Instruments, Inc. with the FDA for Prisma.

Pre-market Notification Details

• Device ID: K791297
• 510k Number: K791297
• Device Name: PRISMA
• Classification: Analyzer, Chemistry (photometric, Discrete), For Clinical Use
• Applicant: LKB INSTRUMENTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: JJE
• CFR Regulation Number: 862.2160 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1979-07-16
• Decision Date: 1979-08-10