Pointe Scientific, Inc. H7506-STD
by Horiba Instruments Incorporated
Pointe Scientific, Inc. H7506-STD is a Class II device made by Horiba Instruments Incorporated, cleared under FDA 510(k) K851432 on 12 Jul 1985 and listed in FDA GUDID since 31 Aug 2016 (UDI-DI 00811727011480), active as of 24 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 | Number00811727011480 | Date31 Aug 2016 | StatusListed |
| United States | FDA 510(k)SESE | NumberK851432 | Date12 Jul 1985 | StatusActive |
Official records
- AccessGUDID record 00811727011480
- FDA 510(k) database K851432
Across registries
- FDA 510(k) K851432 decided 12 Jul 1985 Active
- FDA GUDID UDI-DI 00811727011480 listed 31 Aug 2016 Listed
Timeline
- Cleared FDA 510(k) K851432
- Listed FDA GUDID 00811727011480
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Pointe Scientific, Inc.
- Generic name
- Glycated haemoglobin (HbA1c) IVD, calibrator
- Model / Ref / Catalog
- H7506-STD
- Description
- Reagent intended for use as human hemoglobin standard for the cyanmethemoglobin hemoglobin procedure 1 x 2.0ml
- Primary DI / UDI-DI
- 00811727011480
- 510(k) Number
- FDA product code
- KHG
- GMDN term
- Glycated haemoglobin (HbA1c) IVD, calibrator
- Device class
- Class II
- Regulation number
- 864.7500
- GUDID distribution status
- In Commercial Distribution
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