Mueller Hinton Agar Plates P3318/1&2/P3418/P34181
FDA 510(k) K882351 · Lakewood Biochemical Co., Inc.
510(k) numberK882351
Submission
- Device name
- Mueller Hinton Agar Plates P3318/1&2/P3418/P34181
- Applicant
- Lakewood Biochemical Co., Inc.
Dallas, TX, US - Received
- June 7, 1988
- Decision date
- June 28, 1988
- 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 |
| 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 |
More from bioMerieux, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | 07/01/1988SE |
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | 06/22/1988SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | 06/06/1988SE |
| K880947 | Nutrient Agar Plate, Slant Tube and Broth TubeJSG · Traditional | 04/01/1988SE |
| K880946 | Nutrient Gelatin - Product Number T2860JSF · Traditional | 04/01/1988SE |
| K880945 | Camplyobacter Culture Media Products P3873/T3597JSJ · Traditional | 03/30/1988SE |
| K875136 | Columbia Blood Agar P3308/ Columbia Cna P3750JSG · Traditional | 01/12/1988SE |
| K874538 | Todd-Hewitt Broth (0.5ML)#3099 & (5.OML)#T3516JSG · Traditional | 11/20/1987SE |
| K874537 | Kligler Iron Agar and Triple Sugar Iron AgarJSE · Traditional | 11/20/1987SE |
| K874345 | Tsa W/Neomycin & 5% Sheep Blood - # P3104 & Z3050JSJ · Traditional | 11/06/1987SE |
Questions and answers
When was Mueller Hinton Agar Plates P3318/1&2/P3418/P34181 cleared by the FDA?
Mueller Hinton Agar Plates P3318/1&2/P3418/P34181 (K882351) received a 510(k) decision of Substantially Equivalent on June 28, 1988, 21 days after the submission was received.
What is the product code of K882351?
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.