CDC Anaerobe Blood Agar
FDA 510(k) K854455 · R. Kent Richards, Inc.
510(k) numberK854455
Submission
- Device name
- CDC Anaerobe Blood Agar
- Applicant
- R. Kent Richards, Inc.
Pl. Grove, UT, US - Received
- November 5, 1985
- Decision date
- November 18, 1985
- 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 |
|---|---|---|
| K871065 | Chlamydia & Viral Transport MediumJSM · Traditional | 04/14/1987SE |
| K854457 | Columbia Cna Agar W/5% Sheep BloodJSJ · Traditional | 11/18/1985SE |
| K854456 | Campylobacter Blood AgarJSJ · Traditional | 11/18/1985SE |
| K854454 | Tryptic Soy Blood AgarKZI · Traditional | 11/18/1985SE |
| K854453 | P.E.Z. Agar (Phenylethanol Agar)JSJ · Traditional | 11/18/1985SE |
| K854452 | Mannitol Salt AgarJSI · Traditional | 11/18/1985SE |
| K854451 | Mueller Hinton MediumJTZ · Traditional | 11/18/1985SE |
| K854450 | Bile Esculin Azide AgarJSI · Traditional | 11/18/1985SE |
| K854449 | Hektoen Enteric AgarJSI · Traditional | 11/18/1985SE |
| K854275 | Thayer-Martin Medium (Mod)JTY · Traditional | 11/12/1985SE |
Questions and answers
When was CDC Anaerobe Blood Agar cleared by the FDA?
CDC Anaerobe Blood Agar (K854455) received a 510(k) decision of Substantially Equivalent on November 18, 1985, 13 days after the submission was received.
What is the product code of K854455?
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.