Strep Id Quad
FDA 510(k) K832863 · Troy Biologicals, Inc.
510(k) numberK832863
Submission
- Device name
- Strep Id Quad
- Applicant
- Troy Biologicals, Inc.
Mchenry, IL, US - Received
- August 23, 1983
- Decision date
- September 26, 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
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| 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 |
|---|---|---|
| K861301 | Bacti Plate (Dermatology) Product No. PS-5000JTZ · Traditional | 04/21/1986SE |
| K832862 | Transgrow MediumJTY · Traditional | 09/26/1983SE |
| K832861 | Sabouraud Dextrose AgarJSJ · Traditional | 09/26/1983SE |
| K832860 | SXT Blood AgarJSJ · Traditional | 09/26/1983SE |
| K823311 | Columbia V Agar W/5% Human BloodJSH · Traditional | 12/15/1982SE |
| K823310 | Streptococcus Selective AgarJSI · Traditional | 12/15/1982SE |
| K823307 | Campylobacter Selective AgarJSI · Traditional | 12/15/1982SE |
| K823306 | Hemophilus Quad 10 PlateJSI · Traditional | 12/15/1982SE |
| K823309 | Martin & Lemis Agar W/Vcat InhibitorJTY · Traditional | 12/03/1982SE |
| K823308 | Mycarel Agar Mycobrotic AgarJSJ · Traditional | 12/03/1982SE |
Questions and answers
When was Strep Id Quad cleared by the FDA?
Strep Id Quad (K832863) received a 510(k) decision of Substantially Equivalent on September 26, 1983, 34 days after the submission was received.
What is the product code of K832863?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.