MULTICHECK

Controls For Blood-gases, (assayed And Unassayed)

RADIOMETER AMERICA, INC.

The following data is part of a premarket notification filed by Radiometer America, Inc. with the FDA for Multicheck.

Pre-market Notification Details

• Device ID: K961355
• 510k Number: K961355
• Device Name: MULTICHECK
• Classification: Controls For Blood-gases, (assayed And Unassayed)
• Applicant: RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598
• Contact: Donald L Baker
• Correspondent: Donald L Baker; RADIOMETER AMERICA, INC. 811 SHARON DR. Westlake, OH 44145 -1598
• Product Code: JJS
• CFR Regulation Number: 862.1660 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1996-04-08
• Decision Date: 1996-06-14
• Summary: summary