Buffered Cye Agar Deep W/Supplements
FDA 510(k) K840890 · Remel Co.
510(k) numberK840890
Submission
- Device name
- Buffered Cye Agar Deep W/Supplements
- Applicant
- Remel Co.
Mchenry, IL, US - Received
- February 27, 1984
- Decision date
- March 23, 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 |
|---|---|---|
| K162620 | Remel Spectra ESBLJSO · Traditional | 05/01/2017SE |
| K131804 | Remel Xpect Flu A&BGNX · Special | 07/12/2013SE |
| K092407 | Remel Spectra MrsaJSO · Traditional | 10/08/2010SE |
| K072827 | Rpmi 1640 Agar W/Mops and 2% GlucoseMJE · Traditional | 11/26/2007SE |
| K041951 | Xpect Clostridium Difficile Toxin A/BLLH · Traditional | 11/15/2004SE |
| K033479 | Prospect Clostridium Difficile Toxin A/B Microplate AssayLLH · Traditional | 02/26/2004SE |
| K031942 | Xpect Giardia Lateral Flow Assay, Model 2450020MHI · Traditional | 11/18/2003SE |
| K031965 | Xpect Cryptosporidium Lateral Flow Assay, Model 2451020MHJ · Traditional | 11/14/2003SE |
| K031834 | Xpect Giardia/Cryptosporidium Lateral Flow AssayMHI · Traditional | 11/10/2003SE |
| K031565 | Xpect Influenza A/BPSZ · Traditional | 07/17/2003SE |
Questions and answers
When was Buffered Cye Agar Deep W/Supplements cleared by the FDA?
Buffered Cye Agar Deep W/Supplements (K840890) received a 510(k) decision of Substantially Equivalent on March 23, 1984, 25 days after the submission was received.
What is the product code of K840890?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.