Andwin Scientific 210070
Andwin Scientific 210070 is a papanicolaou smear kit (FDA Class II) made by Andwin Scientific, cleared under FDA 510(k) K930955 on 24 May 1994 (1 earlier submission) and listed in FDA GUDID since 2 Aug 2017 (UDI-DI 00187207000207), active as of 23 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 | Number00187207000207 | Date2 Aug 2017 | StatusListed |
| United States | FDA 510(k) | NumberK930955 | Date24 May 1994 | StatusActive |
Official records
- AccessGUDID record 00187207000207
- FDA 510(k) database K930955
- FDA 510(k) database K890283
Across registries
- FDA 510(k) K930955 decided 24 May 1994 Active
- FDA GUDID UDI-DI 00187207000207 listed 2 Aug 2017 Listed
Timeline
- Cleared FDA 510(k) K890283
- Cleared FDA 510(k) K930955
- Listed FDA GUDID 00187207000207
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Andwin Scientific
- Generic name
- Papanicolaou smear kit
- Model / reference
- 210070
- Primary DI / UDI-DI
- 00187207000207
- FDA product code
- OHL, HHT
- GMDN term
- Papanicolaou smear kit
- Device class
- Class II
- Regulation number
- 884.4530
- GUDID distribution status
- In Commercial Distribution
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