Culture Medium for Pathogenic Neisser
FDA 510(k) K841833 · Microline Scientific
510(k) numberK841833
Submission
- Device name
- Culture Medium for Pathogenic Neisser
- Applicant
- Microline Scientific
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- May 14, 1984
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K841845 | Selective Culture Med. Columbia CnaJSJ · Traditional | 05/31/1984SE |
| K841844 | Differential Culture Medium-Biggy AgarJSI · Traditional | 05/31/1984SE |
| K841843 | Differential Culture Med. Levine EmbJSH · Traditional | 05/31/1984SE |
| K841842 | Differential Culture Med. Macconkey AgarJSI · Traditional | 05/31/1984SE |
| K841586 | Chocolate AgarKZI · Traditional | 05/31/1984SE |
| K841841 | Differential Culture Med. Mannitol SaltJSI · Traditional | 05/25/1984SE |
| K841840 | Selective Culture Med. Phenylethyl AlcoJSJ · Traditional | 05/25/1984SE |
| K841839 | Selective Culture Med. Selective StrepJSJ · Traditional | 05/25/1984SE |
| K841838 | Enriched Culture Med. Tryptic Soy AgarKZI · Traditional | 05/21/1984SE |
| K841837 | Enriched Culture Med. Fluid THIOGLYC0KZI · Traditional | 05/21/1984SE |
Questions and answers
When was Culture Medium for Pathogenic Neisser cleared by the FDA?
Culture Medium for Pathogenic Neisser (K841833) received a 510(k) decision of Substantially Equivalent on May 14, 1984, 27 days after the submission was received.
What is the product code of K841833?
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.