Columbia V Agar W/5% Human Blood
FDA 510(k) K823311 · Troy Biologicals, Inc.
510(k) numberK823311
Submission
- Device name
- Columbia V Agar W/5% Human Blood
- 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
- JSH – Culture Media, Non-Selective And Differential
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2320
- Specialty
- Microbiology
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| K880117 | Of Medium BaseJSH · Traditional | Hardy Media | 03/30/1988SE |
| K873270 | Actinomycete Differential MediaJSH · Traditional | Central Media | 11/04/1987SE |
| K873263 | Maintenance & Carbohydrate Fermentation MediaJSH · Traditional | Central Media | 10/28/1987SE |
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Questions and answers
When was Columbia V Agar W/5% Human Blood cleared by the FDA?
Columbia V Agar W/5% Human Blood (K823311) 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 K823311?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.