Mueller Hinton Agar with 2% Naci
FDA 510(k) K960313 · Remel, L.P.
510(k) numberK960313
Submission
- Device name
- Mueller Hinton Agar with 2% Naci
- Applicant
- Remel, L.P.
Lenexa, KS, US - Received
- January 22, 1996
- Decision date
- March 25, 1996
- 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 |
| 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 |
| K871097 | Chocolate Mueller Hinton AgarJTZ · Traditional | bioMerieux, Inc. | 04/03/1987SE |
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| K961046 | 10B Arginine BrothJSM · Traditional | 09/18/1996SE |
| K955143 | RPR Liquid ControlsGMP · Traditional | 07/30/1996SE |
| K955136 | RPR Card Test KitGMQ · Traditional | 07/29/1996SE |
| K961819 | Streptomycin Disk (300MCG)JTN · Traditional | 07/10/1996SE |
| K961818 | Gentamicin Disk (120MCG)JTN · Traditional | 07/10/1996SE |
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Questions and answers
When was Mueller Hinton Agar with 2% Naci cleared by the FDA?
Mueller Hinton Agar with 2% Naci (K960313) received a 510(k) decision of Substantially Equivalent on March 25, 1996, 63 days after the submission was received.
What is the product code of K960313?
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.