Bacti Plate (Dermatology) Product No. PS-5000
FDA 510(k) K861301 · Troy Biologicals, Inc.
510(k) numberK861301
Submission
- Device name
- Bacti Plate (Dermatology) Product No. PS-5000
- Applicant
- Troy Biologicals, Inc.
Troy, MI, US - Received
- April 7, 1986
- Decision date
- April 21, 1986
- 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 |
|---|---|---|
| K832863 | Strep Id QuadJSI · Traditional | 09/26/1983SE |
| K832862 | Transgrow MediumJTY · Traditional | 09/26/1983SE |
| K832861 | Sabouraud Dextrose AgarJSJ · Traditional | 09/26/1983SE |
| K832860 | SXT Blood AgarJSJ · Traditional | 09/26/1983SE |
| K823311 | Columbia V Agar W/5% Human BloodJSH · Traditional | 12/15/1982SE |
| K823310 | Streptococcus Selective AgarJSI · Traditional | 12/15/1982SE |
| K823307 | Campylobacter Selective AgarJSI · Traditional | 12/15/1982SE |
| K823306 | Hemophilus Quad 10 PlateJSI · Traditional | 12/15/1982SE |
| K823309 | Martin & Lemis Agar W/Vcat InhibitorJTY · Traditional | 12/03/1982SE |
| K823308 | Mycarel Agar Mycobrotic AgarJSJ · Traditional | 12/03/1982SE |
Questions and answers
When was Bacti Plate (Dermatology) Product No. PS-5000 cleared by the FDA?
Bacti Plate (Dermatology) Product No. PS-5000 (K861301) received a 510(k) decision of Substantially Equivalent on April 21, 1986, 14 days after the submission was received.
What is the product code of K861301?
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.