IFA Sensibac Cefaclor
by Investigacion Farmaceutica S.A. DE C.V.
510(k) K892721
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK892721 | Date30 Nov 1989 | StatusActive |
Recalls
No FDA recalls found in the data synced 6 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
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, 28 Sep 2026
IFA Sensibac Cefaclor is a susceptibility test disc used for antimicrobial testing in microbiology laboratories. The device is designed to determine the susceptibility of microorganisms to cefaclor, a cephalosporin antibiotic, through standardized testing methods.
The device is supplied as a single-use product and is classified under product code JTN with FDA 510(k) clearance K892721. It is manufactured by Investigacion Farmaceutica S.A. DE C.V. in Mexico and is regulated under 866.1620. The device is available in various sizes and is intended for laboratory use only.
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Questions
AI-generated answers, 28 Sep 2026
What is the IFA Sensibac Cefaclor used for?
The IFA Sensibac Cefaclor is a susceptibility test disc designed to determine the susceptibility of microorganisms to cefaclor, a cephalosporin antibiotic, through standardized testing methods in microbiology laboratories.
How is the IFA Sensibac Cefaclor supplied and is it reusable?
The device is supplied as a single-use product and is not intended for reuse. It is classified under product code JTN and is available in various sizes for laboratory use only.
What is the regulatory status of the IFA Sensibac Cefaclor?
The IFA Sensibac Cefaclor has FDA 510(k) clearance K892721 and is classified under product code JTN with regulation number 866.1620. It is manufactured by Investigacion Farmaceutica S.A. DE C.V. in Mexico.
What are the storage requirements for the IFA Sensibac Cefaclor?
The device should be stored according to the manufacturer's instructions to maintain its integrity for accurate testing results. Specific storage conditions are not detailed in the provided information.