The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Qbc Malaria System.
| Device ID | K891276 |
| 510k Number | K891276 |
| Device Name: | QBC MALARIA SYSTEM |
| 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 | 1989-03-09 |
| Decision Date | 1989-08-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858092006536 | K891276 | 000 |
| 00858092006109 | K891276 | 000 |
| 00858092006116 | K891276 | 000 |
| 00858092006123 | K891276 | 000 |
| 00858092006130 | K891276 | 000 |
| 00858092006147 | K891276 | 000 |
| 00858092006154 | K891276 | 000 |
| 00858092006161 | K891276 | 000 |
| 00858092006239 | K891276 | 000 |
| 00858092006246 | K891276 | 000 |
| 00858092006314 | K891276 | 000 |
| 00858092006321 | K891276 | 000 |
| 00858092006451 | K891276 | 000 |
| 00858092006468 | K891276 | 000 |
| 00858092006475 | K891276 | 000 |
| 00858092006512 | K891276 | 000 |
| 00858092006529 | K891276 | 000 |
| 00858092006093 | K891276 | 000 |