The following data is part of a premarket notification filed by Organon Teknika Corp. with the FDA for Bact/alert Blood Collection Adapter Cap And Insert.
Device ID | K933939 |
510k Number | K933939 |
Device Name: | BACT/ALERT BLOOD COLLECTION ADAPTER CAP AND INSERT |
Classification | Tubes, Vacuum Sample, With Anticoagulant |
Applicant | ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Contact | Ann M Quinn |
Correspondent | Ann M Quinn ORGANON TEKNIKA CORP. 100 AKZO AVE. Durham, NC 27712 |
Product Code | GIM |
CFR Regulation Number | 862.1675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-08-12 |
Decision Date | 1994-02-07 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03573026125769 | K933939 | 000 |
03573026125752 | K933939 | 000 |