Mueller Hinton Agar Large
FDA 510(k) K864246 · Mds Laboratories, Inc.
510(k) numberK864246
Submission
- Device name
- Mueller Hinton Agar Large
- Applicant
- Mds Laboratories, Inc.
L5j 2m4, CA - Received
- October 28, 1986
- Decision date
- March 31, 1987
- 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 |
|---|---|---|
| K864256 | Tryptone Water (1%)JSF · Traditional | 03/31/1987SE |
| K864255 | Trypticase Soy BrothJSG · Traditional | 03/31/1987SE |
| K864254 | Thioglycollate BrothJSG · Traditional | 03/31/1987SE |
| K864253 | Thayer Martin AgarJTY · Traditional | 03/31/1987SE |
| K864252 | Thayer-Martin JembecJTY · Traditional | 03/31/1987SE |
| K864251 | Selenite F. BrothJSJ · Traditional | 03/31/1987SE |
| K864250 | Sabouraud Dextrose AgarJSJ · Traditional | 03/31/1987SE |
| K864249 | Normal Saline SterileLIB · Traditional | 03/31/1987SE |
| K864248 | Mueller Hinton Agar - SupplementedJTZ · Traditional | 03/31/1987SE |
| K864247 | Mueller Hinton Agar with 5% Sheep BloodJTZ · Traditional | 03/31/1987SE |
Questions and answers
When was Mueller Hinton Agar Large cleared by the FDA?
Mueller Hinton Agar Large (K864246) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 154 days after the submission was received.
What is the product code of K864246?
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.