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 |