Para 12® Plus 230592
by Streck
Para 12® Plus 230592 is a Class II device made by Streck, cleared under FDA 510(k) K901875 on 30 May 1990 and listed in FDA GUDID since 24 Aug 2020 (UDI-DI 30844509000199), 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 | Number30844509000199 | Date24 Aug 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK901875 | Date30 May 1990 | StatusActive |
Official records
- AccessGUDID record 30844509000199
- FDA 510(k) database K901875
Across registries
- FDA 510(k) K901875 decided 30 May 1990 Active
- FDA GUDID UDI-DI 30844509000199 listed 24 Aug 2020 Listed
Timeline
- Cleared FDA 510(k) K901875
- Listed FDA GUDID 30844509000199
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Para 12® Plus
- Generic name
- Full blood count IVD, control
- Model / Ref / Catalog
- 230592
- Primary DI / UDI-DI
- 30844509000199
- 510(k) Number
- FDA product code
- JCN
- GMDN term
- Full blood count IVD, control
- Device class
- Class II
- Regulation number
- 864.8625
- GUDID distribution status
- In Commercial Distribution
- Size
- Total Volume — 3.0 Milliliter
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