Blue Agar
FDA 510(k) K832618 · Carroll Biological Corp.
510(k) numberK832618
Submission
- Device name
- Blue Agar
- Applicant
- Carroll Biological Corp.
Mchenry, IL, US - Received
- July 8, 1983
- Decision date
- September 12, 1983
- 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 |
|---|---|---|
| K832243 | Culture Medium for Antimicrobial SusJTZ · Traditional | 09/29/1983SE |
| K832620 | Tryptic Soy Broth MediaJSC · Traditional | 09/12/1983SE |
| K832619 | Thioglycollate MediumJSC · Traditional | 09/12/1983SE |
| K832617 | Xylose Lysine DeoxycholateJSI · Traditional | 09/12/1983SE |
| K832616 | Macconkey Agar MediaJSH · Traditional | 09/12/1983SE |
| K832615 | SF BrothJSJ · Traditional | 09/12/1983SE |
| K832614 | Selenite BrothJSJ · Traditional | 09/12/1983SE |
| K832613 | Mannitol Salt AgarJSJ · Traditional | 09/12/1983SE |
| K832612 | Chocolate Agar & Thayer Martin AgarJTY · Traditional | 09/12/1983SE |
| K832611 | Tryptic Soy AgarJSG · Traditional | 09/12/1983SE |
Questions and answers
When was Blue Agar cleared by the FDA?
Blue Agar (K832618) received a 510(k) decision of Substantially Equivalent on September 12, 1983, 66 days after the submission was received.
What is the product code of K832618?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.