The following data is part of a premarket notification filed by Becton Dickinson & Co. with the FDA for Bd Max Gbs Assay, Bd Max Instrument.
| Device ID | K111860 |
| 510k Number | K111860 |
| Device Name: | BD MAX GBS ASSAY, BD MAX INSTRUMENT |
| Classification | Nucleic Acid Amplification Assay System, Group B Streptococcus, Direct Specimen Test |
| Applicant | BECTON DICKINSON & CO. 7 LOVETON CIR. Baltimore, MD 21152 |
| Contact | Mary Anne Williams |
| Correspondent | Mary Anne Williams BECTON DICKINSON & CO. 7 LOVETON CIR. Baltimore, MD 21152 |
| Product Code | NJR |
| CFR Regulation Number | 866.3740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-06-30 |
| Decision Date | 2012-02-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 30382904375196 | K111860 | 000 |
| 00382904417727 | K111860 | 000 |