Mycotrium-Gu
FDA 510(k) K822736 · Hana Biologics, Inc.
510(k) numberK822736
Submission
- Device name
- Mycotrium-Gu
- Applicant
- Hana Biologics, Inc.
Walker, MI, US - Received
- September 9, 1982
- Decision date
- December 3, 1982
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K883682 | Chang Medium (Additional Indications)KIT · Traditional | 09/16/1988SE |
| K855205 | Mycotrim TM VL Triphasic Culture SystemJSI · Traditional | 02/05/1986SE |
| K834616 | Amnio Stat-Flm Agglutination TestJHG · Traditional | 05/25/1984SE |
| K833933 | Ace Color TestKQN · Traditional | 03/23/1984SE |
| K822737 | Mycotrium-RsJSI · Traditional | 12/03/1982SE |
| K822150 | Amnistat-FlmJHG · Traditional | 10/21/1982SE |
| K812820 | Chang MediumKIT · Traditional | 11/10/1981SE |
Questions and answers
When was Mycotrium-Gu cleared by the FDA?
Mycotrium-Gu (K822736) received a 510(k) decision of Substantially Equivalent on December 3, 1982, 85 days after the submission was received.
What is the product code of K822736?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.