Precept Ceftizoxime
FDA 510(k) K862560 · Austin Biological Laboratories
510(k) numberK862560
Submission
- Device name
- Precept Ceftizoxime
- Applicant
- Austin Biological Laboratories
Austin, TX, US - Received
- July 3, 1986
- Decision date
- July 11, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K880511 | Xact NeisseriaJSX · Traditional | 08/25/1988SE |
| K874727 | Precept(Tm) CiprofloxacinJWY · Traditional | 02/18/1988SE |
| K870769 | Austin Nonfermenter KitJSW · Traditional | 04/03/1987SE |
| K864069 | Precept (TM) Ticarcillin/Clavulanic AcidJWY · Traditional | 11/13/1986SE |
| K862446 | Precept CeftazidimeJWY · Traditional | 07/11/1986SE |
| K860195 | Precept Trimethoprim/SulfamethoxazoleJWY · Traditional | 02/20/1986SE |
| K860194 | Austin Enteric SystemJSE · Traditional | 02/20/1986SE |
| K854577 | Precept Amoxicillin/Clavvlanic Acid (Augmentin)JWY · Traditional | 02/05/1986SE |
| K853772 | Precept MethicillinLTW · Traditional | 09/16/1985SE |
| K853685 | Precept TM CarbenicillinLTW · Traditional | 09/16/1985SE |
Questions and answers
When was Precept Ceftizoxime cleared by the FDA?
Precept Ceftizoxime (K862560) received a 510(k) decision of Substantially Equivalent on July 11, 1986, 8 days after the submission was received.
What is the product code of K862560?
The FDA product code is JWY – Manual Antimicrobial Susceptibility Test Systems, a Class II (moderate risk) device regulated under 21 CFR 866.1640.