Cycloserine-Cefoxitin Fructose Agar
FDA 510(k) K841218 · Anaerobe Systems
510(k) numberK841218
Submission
- Device name
- Cycloserine-Cefoxitin Fructose Agar
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 22, 1984
- Decision date
- April 5, 1984
- 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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| K881572 | XL Agar BaseJSI · Traditional | Acumedia Manufacturers, Inc. | 04/18/1988SE |
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More from Acumedia Manufacturers, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K844383 | Kanamycin 1000 MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844382 | Vancomycin 5MCG Differential DiskJTO · Traditional | 01/04/1985SE |
| K844381 | Colistin 10 Mcg. Differential DiskJTO · Traditional | 01/04/1985SE |
| K844380 | Bile Differential DiskJTO · Traditional | 01/04/1985SE |
| K841303 | Campylobacter Thioglycollate MedJSG · Traditional | 04/17/1984SE |
| K841142 | Levine Eosin Methylene Blue AgarJSI · Traditional | 04/05/1984SE |
| K841222 | Bacteroides Bile Esculin GarJSI · Traditional | 04/04/1984SE |
| K841221 | Brain Heart Infusion BrothJSC · Traditional | 04/04/1984SE |
| K841220 | Anaerobic Transport MediumJSL · Traditional | 04/04/1984SE |
| K841219 | Shopped Meat CarbohydrateJSC · Traditional | 04/04/1984SE |
Questions and answers
When was Cycloserine-Cefoxitin Fructose Agar cleared by the FDA?
Cycloserine-Cefoxitin Fructose Agar (K841218) received a 510(k) decision of Substantially Equivalent on April 5, 1984, 14 days after the submission was received.
What is the product code of K841218?
The FDA product code is JSI – Culture Media, Selective And Differential, a Class I (low risk) device regulated under 21 CFR 866.2360.