Sceptor Data Management Center Software
FDA 510(k) K891577 · Bd Becton Dickinson Vacutainer Systems Preanalytic
510(k) numberK891577
Submission
- Device name
- Sceptor Data Management Center Software
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
Franklin Lakes, NJ, US - Received
- March 20, 1989
- Decision date
- June 2, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1645
- Specialty
- Microbiology
Other 510(k)s with product code LON
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260282 | VITEK 2 AST-Streptococcus Inducible Clindamycin ResistanceLON · Traditional | bioMerieux, Inc. | 04/15/2026SE |
| K260281 | VITEK 2 AST-Streptococcus Cefuroxime (<=0.125 - >=8 µg/mL)LON · Traditional | Biomerieux | 03/26/2026SE |
| K251579 | VITEK 2 AST-Gram Negative Cefazolin (=<1-=>32 µg/mL)LON · Traditional | bioMerieux, Inc. | 08/21/2025SE |
| K251713 | BD Phoenix Automated Microbiology System - GN Eravacycline (0.125-2 µg/mL)LON · Traditional | Becton, Dickinson and Company | 08/08/2025SE |
| K250447 | BD Phoenix Automated Microbiology System - GN Imipenem-relebactam (0.0625/4 - 16/4 µg/mL)LON · Traditional | Becton, Dickinson and Company | 05/19/2025SE |
| K234012 | Vitek Compact ProLON · Traditional | bioMerieux, Inc. | 03/14/2025SE |
| K250344 | BD Phoenix Automated Microbiology SystemLON · Special | Becton, Dickinson and Company | 03/06/2025SE |
| K233986 | BD Phoenix Automated Microbiology System - GN Ciprofloxacin (0.01564 µg/mL)LON · Traditional | Becton, Dickinson and Company | 03/15/2024SE |
| K234000 | VITEK 2 AST-Gram Positive Lefamulin (<=0.03 - >=4 µg/mL)LON · Traditional | bioMerieux, Inc. | 03/11/2024SE |
| K232756 | ColibríLON · Traditional | Copan Wasp Srl | 12/27/2023SE |
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| K003461 | BD Vacutainer Passive Shielding Blood Collection NeedleFMI · Traditional | 02/01/2001SE |
| K002938 | B-D Ultra-Fine III Pen Needle; Model 31G X 3/16FMI · Traditional | 11/29/2000SE |
| K001364 | BD Directigen Flu A+BPSZ · Traditional | 06/28/2000SE |
| K000762 | Moxifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/25/2000SE |
| K000829 | Gatifloxacin, 5 Ug, BBL Sensi-DiscJTN · Traditional | 04/13/2000SE |
| K993186 | Synercid, 15 Ug, BBL Sensi-DiscJTN · Traditional | 11/03/1999SE |
| K992734 | Becton Dickinson SyringeMEG · Traditional | 10/01/1999SE |
| K992849 | QBC Star Centrifugal Hematology SystemGKZ · Special | 09/23/1999SE |
Questions and answers
When was Sceptor Data Management Center Software cleared by the FDA?
Sceptor Data Management Center Software (K891577) received a 510(k) decision of Substantially Equivalent on June 2, 1989, 74 days after the submission was received.
What is the product code of K891577?
The FDA product code is LON – System, Test, Automated, Antimicrobial Susceptibility, Short Incubation, a Class II (moderate risk) device regulated under 21 CFR 866.1645.