Kultsure STARSWAB(M240), Modification
FDA 510(k) K943499 · Ncs Diagnostics, Inc.
510(k) numberK943499
Submission
- Device name
- Kultsure STARSWAB(M240), Modification
- Applicant
- Ncs Diagnostics, Inc.
Etobicoke, Ontario, CA - Received
- June 13, 1994
- Decision date
- November 30, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JSM – Culture Media, Non-Propagating Transport
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2390
- Specialty
- Microbiology
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More from Copan Italia Spa
| 510(k) | Device | Decision |
|---|---|---|
| K943498 | Kultsure Starswab (M210), ModificationJSM · Traditional | 11/30/1994SE |
| K882811 | StrepslideGTY · Traditional | 10/25/1988SE |
| K881209 | Aso Slide TestGTQ · Traditional | 04/12/1988SE |
| K874019 | StaphslideJWX · Traditional | 10/28/1987SE |
| K871404 | KultsureJSM · Traditional | 04/21/1987SE |
| K870231 | KultsureLIO · Traditional | 02/04/1987SE |
| K860178 | Kultsure (Culture Transport)JSM · Traditional | 04/04/1986SE |
| K860655 | Kultsure (Catalogue No. M200)LIO · Traditional | 03/06/1986SE |
| K860658 | Kultsure (Catalogue No. M250)JSM · Traditional | 03/04/1986SE |
| K860657 | Kultsure (Catalogue No. M240)JSM · Traditional | 03/04/1986SE |
Questions and answers
When was Kultsure STARSWAB(M240), Modification cleared by the FDA?
Kultsure STARSWAB(M240), Modification (K943499) received a 510(k) decision of Substantially Equivalent on November 30, 1994, 170 days after the submission was received.
What is the product code of K943499?
The FDA product code is JSM – Culture Media, Non-Propagating Transport, a Class I (low risk) device regulated under 21 CFR 866.2390.