SIMULTEST IMK PLUS(TM)

Counter, Differential Cell

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Simultest Imk Plus(tm).

Pre-market Notification Details

• Device ID: K900078
• 510k Number: K900078
• Device Name: SIMULTEST IMK PLUS(TM)
• Classification: Counter, Differential Cell
• Applicant: BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Contact: J Arnsberger
• Correspondent: J Arnsberger; BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880
• Product Code: GKZ
• CFR Regulation Number: 864.5220 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1990-01-04
• Decision Date: 1990-04-02

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00382903492176	K900078	000
00382903492114	K900078	000
00382903400423	K900078	000
00382903400416	K900078	000
00382903431168	K900078	000
00382903400485	K900078	000