Apl GN Broth
FDA 510(k) K853613 · Apl Medical Supplies
510(k) numberK853613
Submission
- Device name
- Apl GN Broth
- Applicant
- Apl Medical Supplies
Las Vegas, NV, US - Received
- August 29, 1985
- Decision date
- September 6, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
Other 510(k)s with product code JSH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K881560 | Urea BrothJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881559 | Urea Agar BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881553 | Russell Double Sugar AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881551 | Phenol Red Broth BaseJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881540 | Flo AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881486 | Dnase Test AgarJSH · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
More from Central Media
| 510(k) | Device | Decision |
|---|---|---|
| K853619 | Apl Triple Sugar Iron AgarJSH · Traditional | 09/16/1985SE |
| K853618 | Apl Sim MediumJSH · Traditional | 09/16/1985SE |
| K853617 | Apl Simmons Citrate AgarJSI · 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 |
| K853612 | Apl Dnase Test AgarJSH · Traditional | 09/06/1985SE |
Questions and answers
When was Apl GN Broth cleared by the FDA?
Apl GN Broth (K853613) received a 510(k) decision of Substantially Equivalent on September 6, 1985, 8 days after the submission was received.
What is the product code of K853613?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.