The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Directigen Meningitis Combo Test & (b) Strep Test.
| Device ID | K870155 |
| 510k Number | K870155 |
| Device Name: | DIRECTIGEN MENINGITIS COMBO TEST & (B) STREP TEST |
| Classification | Antisera, All Groups, Streptococcus Spp. |
| 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 | GTZ |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-13 |
| Decision Date | 1987-03-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382902554608 | K870155 | 000 |