Lombard-Dowell Starch Agar
FDA 510(k) K790618 · Anaerobe Systems
510(k) numberK790618
Submission
- Device name
- Lombard-Dowell Starch Agar
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 29, 1979
- Decision date
- April 23, 1979
- 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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| K880121 | Moellers Decarboxylase, BaseJSH · Traditional | Hardy Media | 03/31/1988SE |
| 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 Lombard-Dowell Starch Agar cleared by the FDA?
Lombard-Dowell Starch Agar (K790618) received a 510(k) decision of Substantially Equivalent on April 23, 1979, 25 days after the submission was received.
What is the product code of K790618?
The FDA product code is JSH – Culture Media, Non-Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2320.