Wilkins-Chalgren Anaerobe Agar
by Oxoid U.S.A., Inc. 510(k)
Active
510(k) K811513
Overview
Wilkins-Chalgren Anaerobe Agar is a culture medium used for the isolation, cultivation, and antimicrobial susceptibility testing of anaerobic organisms. It is a dehydrated medium that does not require the addition of blood for use.
The device is supplied as a dehydrated agar medium and is intended for use in microbiology laboratory settings. It is regulated under FDA 510(k) clearance (K811513) and classified as a Class II device under regulation number 866.1700 with product code JSO.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK811513 | Date18 Jun 1981 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- 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
- JSO
- Device Class
- Class II
- Regulation
- 21 CFR Part 866.1700
- Advisory Committee
- Microbiology
- FDA Decision
- SESE Substantially Equivalent