Apl Simmons Citrate Agar
FDA 510(k) K853617 · Apl Medical Supplies
510(k) numberK853617
Submission
- Device name
- Apl Simmons Citrate Agar
- Applicant
- Apl Medical Supplies
Las Vegas, NV, US - Received
- August 29, 1985
- Decision date
- September 16, 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
Other 510(k)s with product code JSI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K853619 | Apl Triple Sugar Iron AgarJSH · Traditional | 09/16/1985SE |
| K853618 | Apl Sim MediumJSH · Traditional | 09/16/1985SE |
| K853610 | Apl Motility Indole Ornithine AgarJSH · Traditional | 09/16/1985SE |
| K853611 | Apl Xylose Lysine Deoxycholate AgarJSI · Traditional | 09/12/1985SE |
| K853609 | Apl Tryptic Soy BrothJSD · Traditional | 09/12/1985SE |
| K853616 | Apl Chlamydospore AgarJSH · Traditional | 09/06/1985SE |
| K853615 | Apl Bile Esculin/Azide AgarJSH · Traditional | 09/06/1985SE |
| K853614 | Apl Fluid Thioglycollate MediumJSH · Traditional | 09/06/1985SE |
| K853613 | Apl GN BrothJSH · Traditional | 09/06/1985SE |
| K853612 | Apl Dnase Test AgarJSH · Traditional | 09/06/1985SE |
Questions and answers
When was Apl Simmons Citrate Agar cleared by the FDA?
Apl Simmons Citrate Agar (K853617) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 18 days after the submission was received.
What is the product code of K853617?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.