Anaerobic Brucella Blood Agar
FDA 510(k) K791562 · Anaerobe Systems
510(k) numberK791562
Submission
- Device name
- Anaerobic Brucella Blood Agar
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- August 14, 1979
- Decision date
- September 17, 1979
- 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 |
|---|---|---|
| K844383 | Kanamycin 1000 MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844382 | Vancomycin 5MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844381 | Colistin 10 Mcg. Differential DiskJTO · Traditional | 01/04/1985SE |
| K844380 | Bile Differential DiskJTO · Traditional | 01/04/1985SE |
| K841303 | Campylobacter Thioglycollate MedJSG · Traditional | 04/17/1984SE |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | 04/05/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | 04/04/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | 04/04/1984SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | 04/04/1984SE |
Questions and answers
When was Anaerobic Brucella Blood Agar cleared by the FDA?
Anaerobic Brucella Blood Agar (K791562) received a 510(k) decision of Substantially Equivalent on September 17, 1979, 34 days after the submission was received.
What is the product code of K791562?
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.