Sterile Trobicin Susceptibility Powder(Sterile Spe
PMA N50407510(k) K902004
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE 510(k) | NumberK902004 | Date15 May 1990 | StatusActive |
| United States | FDA PMA PMA | NumberN50407 | Date30 Jun 1971 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k), FDA PMA Active
Specification
- Generic Name
- Susceptibility test powders, antimicrobial
- PMA Number
- 510(k) Number
- FDA Product Code
- LOP
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1640
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 18 Sep 2026
Sterile Tobicin Susceptibility Powder is a susceptibility test powder, antimicrobial, used to determine the sensitivity of microorganisms to the antibiotic Tobicin. It is supplied in a sterile format for laboratory use in antimicrobial susceptibility testing.
The device is intended for use in microbiology laboratory settings and is supplied sterile. It is a single-use product and is not intended for reuse. Regulatory authorizations include FDA 510(k) clearance (K902004) and FDA PMA (N50407).
Other devices from The Upjohn Co.
Questions
AI-generated answers, 18 Sep 2026
What is the primary use of Sterile Tobicin Susceptibility Powder?
Sterile Tobicin Susceptibility Powder is used in microbiology laboratories to perform antimicrobial susceptibility testing, specifically to determine whether bacteria are sensitive or resistant to the antibiotic Tobicin.
Is Sterile Tobicin Susceptibility Powder sterile and single-use?
Yes, the product is explicitly labeled as sterile and is intended for single-use in laboratory testing procedures; it is not designed for reuse after initial application.
What regulatory authorizations apply to this device?
The device has received both FDA 510(k) clearance under K902004 and FDA PMA approval under N50407, as indicated in the authorization fields of the device data.