Alpha-Tec Systems 0
by CalibreScientific US, Inc. 112 variants
Alpha-Tec Systems 0 is a medical device (FDA Class I; FDA product code JSK, Supplement, Culture Media) made by CalibreScientific US, Inc., cleared under FDA 510(k) K881698 on 13 May 1988 and listed in FDA GUDID since 11 Aug 2022 (UDI-DI 00816085021034), 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 | Number00816085021034 | Date11 Aug 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK881698 | Date13 May 1988 | StatusActive |
Official records
- AccessGUDID record 00816085021034
- FDA 510(k) database K881698
Across registries
- FDA 510(k) K881698 decided 13 May 1988 Active
- FDA GUDID UDI-DI 00816085021034 listed 11 Aug 2022 Listed
Timeline
- Cleared FDA 510(k) K881698
- Listed FDA GUDID 00816085021034
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- Withdrawn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 / reference
- 0
- Primary DI / UDI-DI
- 00816085021034
- 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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