Vacuum Tubes, Pediatric Sizes (J-VAC)
510(k) K760019
Active
510(k)
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK760019 | Date20 Jul 1976 | 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- Withdrawn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) Active
Specification
- 510(k) Number
- FDA Product Code
- GIM
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1675
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
Vacuum tubes, pediatric sizes (J-VAC) are medical devices used for collecting blood samples. These tubes are designed for pediatric patients and are part of the clinical chemistry product category. The device is classified as a vacuum sample tube with anticoagulant.
The device is supplied by Jelco Laboratories and has FDA 510(k) clearance with number K760019. It is a Class II medical device with product code GIM. The device is available in various sizes as indicated by the multiple registration numbers associated with this clearance.