The following data is part of a premarket notification filed by Becton, Dickinson And Company with the FDA for Bd Kiestra Identifa.
| Device ID | K191964 |
| 510k Number | K191964 |
| Device Name: | BD Kiestra IdentifA |
| Classification | Automated System For Sample Preparation And Identification Of Microorganisms From Cultured Isolates By Mass Spectrometry |
| Applicant | Becton, Dickinson And Company 7 Loveton Circle, MC 964 Sparks, MD 21152 |
| Contact | Janine Spafford |
| Correspondent | Laura Stewart Becton, Dickinson And Company 7 Loveton Circle, MC 964 Sparks, MD 21152 |
| Product Code | QQV |
| CFR Regulation Number | 866.3378 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-23 |
| Decision Date | 2021-11-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00382904440633 | K191964 | 000 |