Hemophilus Quad 10 Plate
FDA 510(k) K823306 · Troy Biologicals, Inc.
510(k) numberK823306
Submission
- Device name
- Hemophilus Quad 10 Plate
- Applicant
- Troy Biologicals, Inc.
Mchenry, IL, US - Received
- November 5, 1982
- Decision date
- December 15, 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
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More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
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| K861301 | Bacti Plate (Dermatology) Product No. PS-5000JTZ · Traditional | 04/21/1986SE |
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| 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 |
| 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 Hemophilus Quad 10 Plate cleared by the FDA?
Hemophilus Quad 10 Plate (K823306) received a 510(k) decision of Substantially Equivalent on December 15, 1982, 40 days after the submission was received.
What is the product code of K823306?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.