Azide Agar W/5% Sheep Blood
FDA 510(k) K844934 · American Laboratory Supply, Inc.
510(k) numberK844934
Submission
- Device name
- Azide Agar W/5% Sheep Blood
- Applicant
- American Laboratory Supply, Inc.
Burlington, NC, US - Received
- December 19, 1984
- Decision date
- February 25, 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
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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 |
|---|---|---|
| K852578 | Cled AgarJSH · Traditional | 07/12/1985SE |
| K844933 | Bile Esculin AgarJSI · Traditional | 02/27/1985SE |
| K844932 | Malt AgarJSJ · Traditional | 02/27/1985SE |
| K844931 | Mycological Agar W/AntibioticsJSJ · Traditional | 02/27/1985SE |
| K844930 | Brillant Green AgarJSI · Traditional | 02/27/1985SE |
| K844929 | Inhibitory Mold AgarJSJ · Traditional | 02/27/1985SE |
| K820562 | Campylobacter Selective MediumJSJ · Traditional | 03/19/1982SE |
| K820561 | Sabouraud Dextrose AgarJSJ · Traditional | 03/19/1982SE |
| K820560 | Phenylethanol Agar W/5% Sheep BloodJSJ · Traditional | 03/19/1982SE |
| K820559 | Anaerobe Blood AgarJSG · Traditional | 03/19/1982SE |
Questions and answers
When was Azide Agar W/5% Sheep Blood cleared by the FDA?
Azide Agar W/5% Sheep Blood (K844934) received a 510(k) decision of Substantially Equivalent on February 25, 1985, 68 days after the submission was received.
What is the product code of K844934?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.