CALIBRATOR

Calibrator, Multi-analyte Mixture

PRISMA SYSTEMS

The following data is part of a premarket notification filed by Prisma Systems with the FDA for Calibrator.

Pre-market Notification Details

• Device ID: K943012
• 510k Number: K943012
• Device Name: CALIBRATOR
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440
• Contact: Larry J Beasley
• Correspondent: Larry J Beasley; PRISMA SYSTEMS 1721 BLACK RIVER BLVD. Rome, NY 13440
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-06-24
• Decision Date: 1994-11-28