Mueller Hinton Sensitivity Plate
FDA 510(k) K851518 · Culture Kits, Inc.
510(k) numberK851518
Submission
- Device name
- Mueller Hinton Sensitivity Plate
- Applicant
- Culture Kits, Inc.
Norwich, NY, US - Received
- April 15, 1985
- Decision date
- April 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K945911 | Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton AgarsJTZ · Traditional | Bioclinical Systems, Inc. | 04/04/1995SE |
| 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 |
More from Hardy Media
| 510(k) | Device | Decision |
|---|---|---|
| K911846 | Uri-Three(Tm), ModificationJXA · Traditional | 10/04/1991SE |
| K854672 | Candi-Kit TMJSI · Traditional | 07/11/1986SE |
| K853488 | Staph KitJSI · Traditional | 08/28/1985SE |
| K851225 | Urine DuoJTZ · Traditional | 08/13/1985SE |
| K852582 | Goni-KitJSX · Traditional | 07/12/1985SE |
| K852480 | Derm-KitJSI · Traditional | 07/09/1985SE |
| K850765 | Strep-KitJSJ · Traditional | 04/24/1985SE |
| K850998 | Uri-KitJSG · Traditional | 04/01/1985SE |
Questions and answers
When was Mueller Hinton Sensitivity Plate cleared by the FDA?
Mueller Hinton Sensitivity Plate (K851518) received a 510(k) decision of Substantially Equivalent on April 29, 1985, 14 days after the submission was received.
What is the product code of K851518?
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.