Multichem A1c
510(k) K162514
Multichem A1c is a medical device (FDA Class I; FDA product code JJX, Single (Specified) Analyte Controls (Assayed And Unassayed)) made by Technopath Manufacturing, cleared under FDA 510(k) K162514 on 26 Oct 2016, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162514 | Date26 Oct 2016 | StatusActive |
Official records
- FDA 510(k) database K162514
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JJX
- Device class
- Class I
- Regulation
- 21 CFR Part 862.1660
- Advisory committee
- Clinical Chemistry
- FDA decision
- SESE Substantially Equivalent
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