Poly stat HP20
Poly stat HP20 is a Class I device made by Polymedco, Inc., cleared under FDA 510(k) K980798 on 22 Sep 1998 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 00855574005414), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00855574005414 | Date23 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980798 | Date22 Sep 1998 | StatusActive |
Official records
- AccessGUDID record 00855574005414
- FDA 510(k) database K980798
Across registries
- FDA 510(k) K980798 decided 22 Sep 1998 Active
- FDA GUDID UDI-DI 00855574005414 listed 23 Sep 2016 Listed
Recalls
-
- Ongoing Z-0702-2024
Labeling for affected lots incorrectly indicates the expiration date is 10/31/2023. However, the correct expiration date is 10/31/2022. Use of the product after its expiration may cause false positive, false negative, or invalid results.
Timeline
- Cleared FDA 510(k) K980798
- Listed FDA GUDID 00855574005414
- Recall initiated FDA recalls Z-0702-2024
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Poly stat
- Generic name
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Model / reference
- HP20
- Primary DI / UDI-DI
- 00855574005414
- 510(k) Number
- FDA product code
- LYR
- GMDN term
- Helicobacter pylori antigen IVD, kit, rapid ICT, clinical
- Device class
- Class I
- Regulation number
- 866.3110
- GUDID distribution status
- In Commercial Distribution
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Other devices filed under FDA product code LYR (Helicobacter Pylori).
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