CALIBRATOR

Calibrator, Multi-analyte Mixture

ALKO DIAGNOSTIC CORP.

The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Calibrator.

Pre-market Notification Details

• Device ID: K915797
• 510k Number: K915797
• Device Name: CALIBRATOR
• Classification: Calibrator, Multi-analyte Mixture
• Applicant: ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746
• Contact: Brian J Young
• Correspondent: Brian J Young; ALKO DIAGNOSTIC CORP. ALKO PARK 333 FISKE ST. Holliston, MA 01746
• Product Code: JIX
• CFR Regulation Number: 862.1150 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1991-12-24
• Decision Date: 1992-01-30