Esp Culture System - Myco
FDA 510(k) K953129 · Difco Laboratories, Inc.
510(k) numberK953129
Submission
- Device name
- Esp Culture System - Myco
- Applicant
- Difco Laboratories, Inc.
Livouia, MI, US - Received
- July 6, 1995
- Decision date
- December 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MDB – System, Blood Culturing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2560
- Specialty
- Microbiology
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| K151866 | BD BACTEC Peds Plus/F Culture Vials (plastic)MDB · Traditional | Becton, Dickinson and Company | 02/25/2016SE |
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Questions and answers
When was Esp Culture System - Myco cleared by the FDA?
Esp Culture System - Myco (K953129) received a 510(k) decision of Substantially Equivalent on December 26, 1995, 173 days after the submission was received.
What is the product code of K953129?
The FDA product code is MDB – System, Blood Culturing, a Class I (low risk) device regulated under 21 CFR 866.2560.