Auto-Calcium Reag For Gilford 3400E Anal
by Harleco
510(k) K761029
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 | NumberK761029 | Date30 Nov 1976 | 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- Withdrawn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
- CJY
- Device Class
- Class II
- Regulation
- 21 CFR Part 862.1145
- Advisory Committee
- Clinical Chemistry
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Auto-Calcium Reag For Gilford 3400e Anal is a reagent for use with the Gilford 3400e analyzer, classified as an Azo Dye, Calcium device. It is used in clinical chemistry applications. The device is a type of chemical reagent.
The device is supplied by Harleco and has been cleared by the FDA with a 510K number of K761029. It is classified as a Class II device with the product code CJY. The device was cleared on November 30, 1976.