Culture Medium for Antimicrobial Suscep. Testing
FDA 510(k) K850731 · Roseville Medical Laboratoriesu
510(k) numberK850731
Submission
- Device name
- Culture Medium for Antimicrobial Suscep. Testing
- Applicant
- Roseville Medical Laboratoriesu
Roseville, CA, US - Received
- February 20, 1985
- Decision date
- March 20, 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 |
|---|---|---|
| K850738 | Supplement for Culture MediumJSK · Traditional | 03/20/1985SE |
| K850737 | Transport Culture MediumPPM · Traditional | 03/20/1985SE |
| K850736 | Selective Culture MediumJSI · Traditional | 03/20/1985SE |
| K850734 | Differential Culture MediumJSE · Traditional | 03/20/1985SE |
| K850733 | Multipurpose Culture MediumJSG · Traditional | 03/20/1985SE |
| K850732 | Culture Medium for Pathogenic Neisseria Ssp.MiJTY · Traditional | 03/20/1985SE |
| K850735 | Enriched Culture MediumKZI · Traditional | 03/16/1985SE |
Questions and answers
When was Culture Medium for Antimicrobial Suscep. Testing cleared by the FDA?
Culture Medium for Antimicrobial Suscep. Testing (K850731) received a 510(k) decision of Substantially Equivalent on March 20, 1985, 28 days after the submission was received.
What is the product code of K850731?
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.