Specialty Media
FDA 510(k) K873259 · Central Media
510(k) numberK873259
Submission
- Device name
- Specialty Media
- Applicant
- Central Media
Sacramento, CA, US - Received
- August 11, 1987
- Decision date
- November 6, 1987
- 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 |
|---|---|---|
| K873260 | Corynebacteria Isolation MediaJSI · Traditional | 11/06/1987SE |
| K873258 | Streptococcal Selective Differen. & Enriched MediaJSI · Traditional | 11/06/1987SE |
| K873257 | General Purpose Media W/Select. & Diff. Modifica.JSG · Traditional | 11/06/1987SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | 11/04/1987SE |
| K873269 | Mycological MediaJSI · Traditional | 11/04/1987SE |
| K873268 | Mueller Hinton MediaJTZ · Traditional | 11/04/1987SE |
| K873267 | ECG Based MediaKZI · Traditional | 11/04/1987SE |
| K873266 | Middlebrook Based MediaKZI · Traditional | 10/28/1987SE |
| K873265 | Media for Anaerobic/Microaerphilic IsolationJSI · Traditional | 10/28/1987SE |
| K873264 | Media for Detection & Verification of ColiformsJSI · Traditional | 10/28/1987SE |
Questions and answers
When was Specialty Media cleared by the FDA?
Specialty Media (K873259) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 87 days after the submission was received.
What is the product code of K873259?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.