Aeromonas Agar(Xdca)
FDA 510(k) K852789 · Gibco Laboratories Life Technologies, Inc.
510(k) numberK852789
Submission
- Device name
- Aeromonas Agar(Xdca)
- Applicant
- Gibco Laboratories Life Technologies, Inc.
Madison, WI, US - Received
- July 1, 1985
- Decision date
- July 19, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSI – Culture Media, Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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|---|---|---|---|
| K070691 | BBL Chromagar 0157JSI · Traditional | Becton, Dickinson & CO | 11/20/2007SE |
| K974428 | DipstreakJSI · Traditional | Novamed , Ltd. | 07/30/1998SE |
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | Oxoid U.S.A., Inc. | 06/09/1989SE |
| K890199 | Dentocult Sm-Strip MutansJSI · Traditional | Orion Corp. | 03/02/1989SE |
| K882182 | Salmonella-Shigella (SS) Agar - Product #P3326JSI · Traditional | Lakewood Biochemical Co., Inc. | 06/06/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881556 | Trichomonas BrothJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K871855 | Sorbitol Macconkey (Smac) Agar, Dri & Pre-FormJSH · Traditional | 05/26/1987SE |
| K871541 | Martin-Lewis Agar W/Reduced Vancomycin C0226JTY · Traditional | 04/29/1987SE |
| K870134 | Mcbride Listeria Agar W/Cycloheximide, Dri & PreJSJ · Traditional | 02/04/1987SE |
| K864755 | Pseudomonas Cepacia Selective Agar, Dri & Pre-FormJSJ · Traditional | 01/05/1987SE |
| K864014 | Lombard Dowell Agar BaseKZI · Traditional | 10/29/1986SE |
| K863821 | Mueller Hinton Agar W/4%NACL and OxacillinJTZ · Traditional | 10/09/1986SE |
| K863820 | Dri-Form: Gbna Listeria Medium No. M22300JSJ · Traditional | 10/08/1986SE |
| K863289 | CDC Anaerobic Agar W/Sheep Blood, Kana-&VancomycinJSJ · Traditional | 09/03/1986SE |
| K862425 | Macconkey Agar W/Mug, Dri-Form and Pre-FormJSI · Traditional | 07/02/1986SE |
| K861058 | Sensititre Auto Id Plate, AP70JTO · Traditional | 05/20/1986SE |
Questions and answers
When was Aeromonas Agar(Xdca) cleared by the FDA?
Aeromonas Agar(Xdca) (K852789) received a 510(k) decision of Substantially Equivalent on July 19, 1985, 18 days after the submission was received.
What is the product code of K852789?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.