PeraChek 1701-01
PeraChek 1701-01 is a Class II device made by Angelini Pharma Inc., cleared under FDA 510(k) K980164 on 16 Apr 1998 and listed in FDA GUDID since 23 May 2017 (UDI-DI 00898021000242), 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 | Number00898021000242 | Date23 May 2017 | StatusListed |
| United States | FDA 510(k)SESE | NumberK980164 | Date16 Apr 1998 | StatusActive |
Official records
- AccessGUDID record 00898021000242
- FDA 510(k) database K980164
Across registries
- FDA 510(k) K980164 decided 16 Apr 1998 Active
- FDA GUDID UDI-DI 00898021000242 listed 23 May 2017 Listed
Timeline
- Cleared FDA 510(k) K980164
- Listed FDA GUDID 00898021000242
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- PeraChek
- Generic name
- Hydrogen peroxide device disinfectant/sterilant test strip
- Model / Ref / Catalog
- 1701-01
- Primary DI / UDI-DI
- 00898021000242
- 510(k) Number
- FDA product code
- MSY, LIF
- GMDN term
- Hydrogen peroxide device disinfectant/sterilant test strip
- Device class
- Class II
- Regulation number
- 876.5665, 876.5820
- GUDID distribution status
- In Commercial Distribution
- Size
- Width — 0.2 InchLength — 3.25 Inch
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