Sensititre 18 Hour Susceptibility Plates
FDA 510(k) K960366 · Accumed Intl., Inc.
510(k) numberK960366
Submission
- Device name
- Sensititre 18 Hour Susceptibility Plates
- Applicant
- Accumed Intl., Inc.
Westlake, OH, US - Received
- January 25, 1996
- Decision date
- April 9, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LTT – Panels, Test, Susceptibility, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | Beckman Coulter, Inc. | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 08/15/2025SE |
| K250084 | MicroScan Dried Gram-Negative MIC/Combo Panels with Aztreonam (AZT) (0.5-64 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 07/18/2025SE |
| K202343 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ceftazidime (Caz) (0.5-64 µg/mL )LTT · Traditional | Beckman Coulter, Inc. | 11/16/2020SE |
| K201423 | MicroScan Dried Gram-Negative MIC/Combo Panels with Meropenem (Mer) (0.004-32 µg/mL)LTT · Special | Beckman Coulter, Inc. | 06/29/2020SE |
| K193536 | MicroScan Dried Gram Negative MIC/Combo Panels with Ciprofloxacin (Cp) (0.004 - 8µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/18/2020SE |
| K193358 | MicroScan Dried Gram-Negative MIC/Combo Panels with Levofloxacin (Lvx) (0.008-16ug/mL)LTT · Traditional | Beckman Coulter, Inc. | 03/03/2020SE |
| K183127 | MicroScan Dried Gram Negative MIC/Combo Panels with Meropenem/Vaborbactam…LTT · Traditional | Beckman Coulter, Inc. | 02/12/2019SE |
| K172337 | MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4…LTT · Traditional | Beckman Coulter, Inc. | 12/15/2017SE |
| K172912 | MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 8 µg/mL)LTT · Traditional | Beckman Coulter, Inc. | 12/07/2017SE |
More from Beckman Coulter, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K984489 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 02/16/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | 12/18/1998SE |
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | 12/17/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | 12/14/1998SE |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with TrovafloxacinJWY · Traditional | 11/25/1998SE |
| K982786 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 10/16/1998SE |
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | 01/22/1998SE |
| K964689 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 08/18/1997SE |
| K972756 | Modification of Est Culture System II - MycoMDB · Traditional | 08/01/1997SE |
| K965190 | Sensititre Haemophilus/Streptococcus Pneumoniae Mic PlateJWY · Traditional | 03/19/1997SE |
Questions and answers
When was Sensititre 18 Hour Susceptibility Plates cleared by the FDA?
Sensititre 18 Hour Susceptibility Plates (K960366) received a 510(k) decision of Substantially Equivalent on April 9, 1996, 75 days after the submission was received.
What is the product code of K960366?
The FDA product code is LTT – Panels, Test, Susceptibility, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.