Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars
FDA 510(k) K945911 · Bioclinical Systems, Inc.
510(k) numberK945911
Submission
- Device name
- Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars
- Applicant
- Bioclinical Systems, Inc.
Annapolis Junction, MD, US - Received
- December 2, 1994
- Decision date
- April 4, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JTZ – Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1700
- Specialty
- Microbiology
Other 510(k)s with product code JTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K132491 | Mueller Hinton AgarJTZ · Traditional | Edge Biologicals, Inc. | 06/30/2014SE |
| K963036 | Mueller Hinton II Broth (Cation-Adjusted) with Lysed Horse BloodJTZ · Traditional | Becton Dickinson Microbiology Systems | 10/07/1996SE |
| K960420 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | Becton Dickinson Microbiology Systems | 04/04/1996SE |
| K960313 | Mueller Hinton Agar with 2% NaciJTZ · Traditional | Remel, L.P. | 03/25/1996SE |
| K941985 | Mueller Hinton Agar W/OxacillinJTZ · Traditional | Carr-Scarborough Microbiologicals, Inc. | 08/24/1994SE |
| K882351 | Mueller Hinton Agar Plates P3318/1&2/P3418/P34181JTZ · Traditional | Lakewood Biochemical Co., Inc. | 06/28/1988SE |
| K880105 | Muller Hinton BrothJTZ · Traditional | Hardy Media | 03/30/1988SE |
| K873268 | Mueller Hinton MediaJTZ · Traditional | Central Media | 11/04/1987SE |
| K870649 | Mrsa Screen Agar (Mueller Hinton W/Nacl & Oxacil.)JTZ · Traditional | Hardy Media | 04/14/1987SE |
| K871097 | Chocolate Mueller Hinton AgarJTZ · Traditional | bioMerieux, Inc. | 04/03/1987SE |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | 06/30/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | 02/03/1994SE |
| K873086 | Round 1JXA · Traditional | 08/24/1987SE |
| K860334 | Visi-Check HLH Test MonoclonalCEP · Traditional | 04/21/1986SE |
| K860333 | Micro-Elisa HLH Test Kit MonoclonalCEP · Traditional | 04/21/1986SE |
| K855227 | Micro-Eia Theophylline Test Kit MonoclonalKLS · Traditional | 04/11/1986SE |
| K854059 | Micro-Elisa HCG Est Kit Visi-Check HCG Test Kit NoJHI · Traditional | 01/13/1986SE |
| K854379 | Micro-Elisa TSH Test Kit-Visi-Check TSH Test KitJLW · Traditional | 01/07/1986SE |
| K850257 | BCS Glucose Colorimetric TestCGA · Traditional | 03/05/1985SE |
Questions and answers
When was Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars cleared by the FDA?
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agars (K945911) received a 510(k) decision of Substantially Equivalent on April 4, 1995, 123 days after the submission was received.
What is the product code of K945911?
The FDA product code is JTZ – Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth, a Class II (moderate risk) device regulated under 21 CFR 866.1700.