Selective Culture Med. Columbia Cna
FDA 510(k) K841845 · Microline Scientific
510(k) numberK841845
Submission
- Device name
- Selective Culture Med. Columbia Cna
- Applicant
- Microline Scientific
Mchenry, IL, US - Received
- April 17, 1984
- Decision date
- May 31, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
Other 510(k)s with product code JSJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K841836 | Selective Culture Med. TrichomonasJSD · Traditional | 05/14/1984SE |
Questions and answers
When was Selective Culture Med. Columbia Cna cleared by the FDA?
Selective Culture Med. Columbia Cna (K841845) received a 510(k) decision of Substantially Equivalent on May 31, 1984, 44 days after the submission was received.
What is the product code of K841845?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.