CDS-LTX PRIMER 6 x 16mL
by Clinical Diagnostic Solutions, Inc.
CDS-LTX PRIMER 6 x 16mL (502-007) is a Class II device made by Clinical Diagnostic Solutions, Inc., cleared under FDA 510(k) K993375 on 20 Dec 1999 and listed in FDA GUDID since 8 Sep 2016 (UDI-DI 00812137010261), 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 | Number00812137010261 | Date8 Sep 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK993375 | Date20 Dec 1999 | StatusActive |
Official records
- AccessGUDID record 00812137010261
- FDA 510(k) database K993375
Across registries
- FDA 510(k) K993375 decided 20 Dec 1999 Active
- FDA GUDID UDI-DI 00812137010261 listed 8 Sep 2016 Listed
Timeline
- Cleared FDA 510(k) K993375
- Listed FDA GUDID 00812137010261
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Cds-Ltx Primer
- Generic name
- Reticulocyte count IVD, control
- Model / Ref / Catalog
- 6 x 16mL, 502-007
- Primary DI / UDI-DI
- 00812137010261
- 510(k) Number
- FDA product code
- KRY
- GMDN term
- Reticulocyte count IVD, control
- Device class
- Class II
- Regulation number
- 864.8175
- GUDID distribution status
- In Commercial Distribution
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