Alpha-Tec Systems 0
by CalibreScientific US, Inc. 112 variants
Alpha-Tec Systems 0 (X003442) is a Class I device made by CalibreScientific US, Inc., cleared under FDA 510(k) K881879 on 13 May 1988 and listed in FDA GUDID since 10 Aug 2022 (UDI-DI 00816085020716), 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 | GUDID listing | Number00816085020716 | Date10 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK881879 | Date13 May 1988 | StatusActive |
Official records
- AccessGUDID record 00816085020716
- FDA 510(k) database K881879
Across registries
- FDA 510(k) K881879 decided 13 May 1988 Active
- FDA GUDID UDI-DI 00816085020716 listed 10 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K881879
- Listed FDA GUDID 00816085020716
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Alpha-Tec Systems
- Generic name
- Sputum specimen liquefaction/decontamination kit IVD
- Model / Ref / Catalog
- 0, X003442
- Primary DI / UDI-DI
- 00816085020716
- 510(k) Number
- FDA product code
- JSK
- GMDN term
- Sputum specimen liquefaction/decontamination kit IVD
- Device class
- Class I
- Regulation number
- 866.2450
- GUDID distribution status
- In Commercial Distribution
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