The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Anti-cytokeratin Monoclonal Antibody.
| Device ID | K864893 |
| 510k Number | K864893 |
| Device Name: | ANTI-CYTOKERATIN MONOCLONAL ANTIBODY |
| Classification | Cytokeratins |
| Applicant | BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Contact | Russell Arnsberger |
| Correspondent | Russell Arnsberger BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes, NJ 07417 -1880 |
| Product Code | LYE |
| CFR Regulation Number | 866.5550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-15 |
| Decision Date | 1988-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903492053 | K864893 | 000 |