MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578

Tubes, Vials, Systems, Serum Separators, Blood Collection

BECTON DICKINSON VACUTAINER SYSTEMS

The following data is part of a premarket notification filed by Becton Dickinson Vacutainer Systems with the FDA for Microtainer Brand Chemistry Tubes With Microgard Closure, Model 365965, 365985, 365963, 365967, 36578.

Pre-market Notification Details

• Device ID: K991702
• 510k Number: K991702
• Device Name: MICROTAINER BRAND CHEMISTRY TUBES WITH MICROGARD CLOSURE, MODEL 365965, 365985, 365963, 365967, 36578
• Classification: Tubes, Vials, Systems, Serum Separators, Blood Collection
• Applicant: BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885
• Contact: Andrea Hroncicch
• Correspondent: Andrea Hroncicch; BECTON DICKINSON VACUTAINER SYSTEMS ONE BECTON DR. Franklin Lakes, NJ 07417 -1885
• Product Code: JKA
• CFR Regulation Number: 862.1675 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1999-05-19
• Decision Date: 1999-07-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
50382903659871	K991702	000
30382903659655	K991702	000
30382903659877	K991702	000
30382903659631	K991702	000
30382903659785	K991702	000
30382903659853	K991702	000
50382903659635	K991702	000
50382903659659	K991702	000
50382903659673	K991702	000
50382903659741	K991702	000
50382903659789	K991702	000
50382903659857	K991702	000
30382903659679	K991702	000