Brucella Broth
FDA 510(k) K833887 · Oxoid U.S.A., Inc.
510(k) numberK833887
Submission
- Device name
- Brucella Broth
- Applicant
- Oxoid U.S.A., Inc.
Mchenry, IL, US - Received
- November 9, 1983
- Decision date
- December 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSJ – Culture Media, Selective And Non-Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2360
- Specialty
- Microbiology
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| K882463 | Potato Dextrose Agar (Pda) - Product #P3421JSJ · Traditional | Lakewood Biochemical Co., Inc. | 06/22/1988SE |
| K881578 | StreptoselJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881574 | W-L Differential MediumJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881573 | Phytone Yeast Extract AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881571 | Ym BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881570 | Sabouraud Maltose AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881565 | Inhibitory Mold AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881561 | Tergitol 7 BrothJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881549 | Mycological Agar W/Low PHJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
| K881547 | Mitis Salivarius AgarJSJ · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K891593 | Listeria Selective Enrichment MediumJSI · Traditional | 06/09/1989SE |
| K884026 | Escherichia Coli 0157 Latex Agglutination Test KitGNA · Traditional | 02/03/1989SE |
| K884208 | Listeria Selective Medium (Oxford Formulation)KZI · Traditional | 10/25/1988SE |
| K874303 | Staphylase TestLHT · Traditional | 11/06/1987SE |
| K872956 | Sorbitol Macconkey Agar No. 3 CM 813JSI · Traditional | 08/10/1987SE |
| K872135 | Mcbride Medium CM 819JSJ · Traditional | 06/15/1987SE |
| K870945 | Rabbit Plasma Fibrinogen Supplement SR 122JTL · Traditional | 06/10/1987SE |
| K862946 | Oxoid Signal Blood Culture SystemJSG · Traditional | 11/05/1986SE |
| K855236 | Diagnostic Reagent Tst-RplaGTN · Traditional | 11/04/1986SE |
| K855235 | Diagnostic Reagent Pet-RplaJSP · Traditional | 11/04/1986SE |
Questions and answers
When was Brucella Broth cleared by the FDA?
Brucella Broth (K833887) received a 510(k) decision of Substantially Equivalent on December 12, 1983, 33 days after the submission was received.
What is the product code of K833887?
The FDA product code is JSJ – Culture Media, Selective And Non-Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.