Chocolate Mueller Hinton Agar
FDA 510(k) K851579 · Preferred Micro-Media
510(k) numberK851579
Submission
- Device name
- Chocolate Mueller Hinton Agar
- Applicant
- Preferred Micro-Media
Toledo, OH, US - Received
- April 16, 1985
- Decision date
- May 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTY – Culture Media, For Isolation Of Pathogenic Neisseria
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.2410
- Specialty
- Microbiology
Other 510(k)s with product code JTY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K210511 | InTray GCJTY · Traditional | Biomed Diagnostics Incorporated | 10/20/2021SE |
| K993033 | Intray GCJTY · Traditional | Biomed Diagnostics, Inc. | 12/16/1999SE |
| K954986 | GC Base W/ 1% GchiJTY · Traditional | Remel, L.P. | 02/16/1996SE |
| K950196 | Culture Media, for Isolation of Pathogenic NeisseriaJTY · Traditional | Bioclinical Systems, Inc. | 06/30/1995SE |
| K933122 | Microbiological Culture Media,Martin Lewis AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/09/1994SE |
| K933121 | Microbiological Culture Media,Chocolate AgarJTY · Traditional | Bioclinical Systems, Inc. | 02/03/1994SE |
| K934331 | Thayer Martin, Modified Pill PocketJTY · Traditional | Hardy Diagnostics | 12/21/1993SE |
| K934330 | TransgrowJTY · Traditional | Hardy Diagnostics | 12/17/1993SE |
| K931864 | Martin Lewis with LinocmycinJTY · Traditional | Hardy Diagnostics | 12/15/1993SE |
| K881552 | Proteose No. 3 AgarJTY · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K851594 | SF BrothJSI · Traditional | 05/14/1985SE |
| K851597 | Triple Sugar Iron AgarJSH · Traditional | 05/13/1985SE |
| K851596 | Sim MediumJSH · Traditional | 05/13/1985SE |
| K851595 | Simmons Citrate AgarJSH · Traditional | 05/13/1985SE |
| K851593 | Selective Streptococcus AgarJSJ · Traditional | 05/13/1985SE |
| K851592 | Sabouraud Dextrose AgarJSJ · Traditional | 05/13/1985SE |
| K851591 | Phenylethyl Alcohol Agar W/5%SHEEP BloodJSJ · Traditional | 05/13/1985SE |
| K851598 | Thioglycollate Without IndicatorJSG · Traditional | 05/10/1985SE |
| K851576 | Biggy Agar Nickersons MediumJSH · Traditional | 05/09/1985SE |
| K851603 | Xylose Lysine Desoxycholate AgarJSI · Traditional | 05/08/1985SE |
Questions and answers
When was Chocolate Mueller Hinton Agar cleared by the FDA?
Chocolate Mueller Hinton Agar (K851579) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 22 days after the submission was received.
What is the product code of K851579?
The FDA product code is JTY – Culture Media, For Isolation Of Pathogenic Neisseria, a Class II (moderate risk) device regulated under 21 CFR 866.2410.