Ceftazidime 30 Mcg Sensitvity Discs
by Difco Laboratories, Inc. 510(k)
Active
510(k) K852835
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK852835 | Date12 Aug 1985 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 6 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- JTN
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1620
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 27 Sep 2026
Ceftazidime 30 Mcg Sensitivity Discs are antimicrobial susceptibility test discs used in microbiology laboratories. These discs are designed for disc diffusion testing to determine the susceptibility of microorganisms to the antibiotic ceftazidime.
This device is identified under product code JTN and is regulated under 21 CFR 866.1620. It has received FDA 510(k) clearance for use in clinical laboratory settings. Users should refer to the manufacturer's instructions for specific storage and handling requirements.
Other devices from Difco Laboratories, Inc.
Questions
AI-generated answers, 27 Sep 2026
What is the primary use of Ceftazidime 30 Mcg Sensitivity Discs?
These discs are intended for use in microbiology laboratories to perform disc diffusion testing. This procedure determines the susceptibility of specific microorganisms to the antibiotic ceftazidime.
What regulatory status do these sensitivity discs hold?
The Ceftazidime 30 Mcg Sensitivity Discs have received FDA 510(k) clearance for use in clinical laboratory settings. They are classified as a class 2 medical device under 21 CFR 866.1620.
How should these discs be stored and handled?
Users must refer to the specific manufacturer instructions provided by Difco Laboratories, Inc. for the appropriate storage and handling requirements to ensure the integrity of the antimicrobial discs.