The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Simultest(tm) Imk-lymphocyte.
| Device ID | K913192 |
| 510k Number | K913192 |
| Device Name: | SIMULTEST(TM) IMK-LYMPHOCYTE |
| 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 | 1991-07-18 |
| Decision Date | 1992-02-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382903401826 | K913192 | 000 |
| 00382903400447 | K913192 | 000 |
| 00382903400430 | K913192 | 000 |