Anaerobe Blood Agar
FDA 510(k) K820559 · American Laboratory Supply, Inc.
510(k) numberK820559
Submission
- Device name
- Anaerobe Blood Agar
- Applicant
- American Laboratory Supply, Inc.
Mchenry, IL, US - Received
- March 2, 1982
- Decision date
- March 19, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSG – Culture Media, Non-Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2300
- Specialty
- Microbiology
Other 510(k)s with product code JSG
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K882495 | Thioglycollate Broth W/Vita. K & Hemin - #T3007JSG · Traditional | Lakewood Biochemical Co., Inc. | 07/01/1988SE |
| K881564 | Tryptose Blood Agar Base W/Yeast ExtractJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881563 | Tryptose Phosphate BrothJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881562 | Tryptose Blood Agar BaseJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881558 | Tryptose AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881557 | TryptoneJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881554 | Skim Milk DehydratedJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881550 | Of Basal MediumJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881548 | MPH AgarJSG · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881546 | Malt Extract AgarJSG · 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 |
| K844934 | Azide Agar W/5% Sheep BloodJSI · Traditional | 02/25/1985SE |
| 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 |
Questions and answers
When was Anaerobe Blood Agar cleared by the FDA?
Anaerobe Blood Agar (K820559) received a 510(k) decision of Substantially Equivalent on March 19, 1982, 17 days after the submission was received.
What is the product code of K820559?
The FDA product code is JSG – Culture Media, Non-Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2300.