Gram Positive Dried Overnight Panels/Lomeflox
FDA 510(k) K941459 · Baxter Diagnostics, Inc.
510(k) numberK941459
Submission
- Device name
- Gram Positive Dried Overnight Panels/Lomeflox
- Applicant
- Baxter Diagnostics, Inc.
Mcgaw Park, IL, US - Received
- March 24, 1994
- Decision date
- February 3, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JWY – Manual Antimicrobial Susceptibility Test Systems
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code JWY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260447 | ETEST Gepotidacin (GEP) (0.016-256 µg/mL)JWY · Traditional | bioMérieux SA | 04/21/2026SE |
| K260696 | MTS Gepotidacin 0.016-256 µg/mLJWY · Traditional | Liofilchem s.r.l. | 04/17/2026SE |
| K252114 | MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mLJWY · Traditional | Liofilchem s.r.l. | 10/02/2025SE |
| K252062 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Colistin in the…JWY · Traditional | Thermo Fisher Scientific | 09/25/2025SE |
| K250575 | The Sensititre 18 - 24 hour MIC or Breakpoint Susceptibility System with…JWY · Traditional | Thermo Fisher Scientific | 09/05/2025SE |
| K252014 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Amikacin in the…JWY · Traditional | Thermo Fisher Scientific | 08/28/2025SE |
| K251580 | MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)JWY · Traditional | Liofilchem s.r.l. | 08/20/2025SE |
| K250990 | The Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Ciprofloxacin in…JWY · Traditional | Thermo Fisher Scientific | 06/30/2025SE |
| K242843 | The Sensititre 20-24 hour Haemophilus influenzae/Streptococcus pneumoniae (HP) MIC or…JWY · Traditional | Thermo Fisher Scientific | 06/20/2025SE |
| K250856 | ETEST Aztreonam/Avibactam (AZA) (0.016/4-256/4 µg/mL)JWY · Traditional | Biomérieux | 06/12/2025SE |
More from Biomérieux
| 510(k) | Device | Decision |
|---|---|---|
| K934458 | Dried Gram-Positive Mic/Combo PanelsJWY · Traditional | 07/18/1995SE |
| K950817 | Dried Gram Positive Mic/Combo Panels/PneumococciJWY · Traditional | 04/25/1995SE |
| K935704 | Dried Gram-Negative Mic//Combo PanelsLTT · Traditional | 04/14/1995SE |
| K950570 | Stratus Progesterone Fluorometric Enzyme ImmunoassayJLS · Traditional | 04/11/1995SE |
| K945235 | Dried Gram-Positive Mic/Combo PanelsLTT · Traditional | 03/07/1995SE |
| K941030 | Dried Gram-Negative CefpodoximeLTT · Traditional | 02/16/1995SE |
| K940917 | Loracarbef Gram-Nagative PanelsJWY · Traditional | 02/08/1995SE |
| K941317 | Dried Gram Negative/CefmetazoleJWY · Traditional | 01/31/1995SE |
| K942267 | Dried Gram-Positive Mic/Combo Panels/CefmetazoleJWY · Traditional | 01/09/1995SE |
| K942089 | Microdilution/Loracarbef PanelsJWY · Traditional | 01/09/1995SE |
Questions and answers
When was Gram Positive Dried Overnight Panels/Lomeflox cleared by the FDA?
Gram Positive Dried Overnight Panels/Lomeflox (K941459) received a 510(k) decision of Substantially Equivalent on February 3, 1995, 316 days after the submission was received.
What is the product code of K941459?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.