Flo Agar
FDA 510(k) K881540 · Acumedia Manufacturers, Inc.
510(k) numberK881540
Submission
- Device name
- Flo Agar
- Applicant
- Acumedia Manufacturers, Inc.
Baltimore, MD, US - Received
- April 8, 1988
- Decision date
- April 18, 1988
- 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 |
| 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 |
| K873411 | Simmons Citrate Medium Slant, Product #T3084JSH · Traditional | Lakewood Biochemical Co., Inc. | 10/06/1987SE |
More from Lakewood Biochemical Co., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K881579 | Amies Transport Medium W/O CharcoalJSN · Traditional | 04/18/1988SE |
| K881578 | StreptoselJSJ · Traditional | 04/18/1988SE |
| K881577 | Modified Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881576 | Selenite BrothJSI · Traditional | 04/18/1988SE |
| K881575 | Selective Streptococcus AgarJSI · Traditional | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | 04/18/1988SE |
| K881572 | XL Agar BaseJSI · Traditional | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | 04/18/1988SE |
Questions and answers
When was Flo Agar cleared by the FDA?
Flo Agar (K881540) received a 510(k) decision of Substantially Equivalent on April 18, 1988, 10 days after the submission was received.
What is the product code of K881540?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.