Anaerobic Transport Medium
FDA 510(k) K841220 · Anaerobe Systems
510(k) numberK841220
Submission
- Device name
- Anaerobic Transport Medium
- Applicant
- Anaerobe Systems
Mchenry, IL, US - Received
- March 22, 1984
- Decision date
- April 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JSL – Culture Media, Anaerobic Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
Other 510(k)s with product code JSL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972449 | Copan Venturi Transystem Amies Medium with CharcoalJSL · Traditional | Copan Italia Spa | 08/20/1997SE |
| K972448 | Copan Venturi Transystem Amies Medium Without CharcoalJSL · Traditional | Copan Italia Spa | 08/20/1997SE |
| K944847 | Kultsure/Starswab Anaerobic Transport SystemJSL · Traditional | Starplex Scientific, Inc. | 02/16/1995SE |
| K925450 | Bionor TransportmediumJSL · Traditional | Skoug Research Corp. | 06/25/1993SE |
| K834357 | Ana Trans Tube & Swabs Sterile PackJSL · Traditional | Anaerobe Systems | 01/31/1984SE |
| K770840 | Pre-Reduced Anaerobic MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 06/08/1977SE |
| K770650 | Pre-Duced Culture MediaJSL · Traditional | Gibco Laboratories Life Technologies, Inc. | 04/15/1977SE |
More from Gibco Laboratories Life Technologies, 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 |
| K841218 | Cycloserine-Cefoxitin Fructose AgarJSI · Traditional | 04/05/1984SE |
| 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 |
| K841219 | Shopped Meat CarbohydrateJSC · Traditional | 04/04/1984SE |
Questions and answers
When was Anaerobic Transport Medium cleared by the FDA?
Anaerobic Transport Medium (K841220) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 13 days after the submission was received.
What is the product code of K841220?
The FDA product code is JSL – Culture Media, Anaerobic Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.