Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers
510(k) K951071
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK951071 | Date24 Jul 1995 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KRZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 864.8165
- Advisory Committee
- Hematology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
The Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers is a calibrator for hemoglobin and hematocrit measurement, classified as a device for hematology. It is designed for use with Corning 280, 288, and 2500 analyzers. The device is used in the field of hematology. It is a type of calibrator, specifically for hemoglobin and hematocrit measurement.
The Alko Slope Thb Solution For Corning 280, 288 And 2500 Analyzers is supplied by Alko Diagnostic Corp. It has been cleared under FDA 510(k) with the k-number K951071. The device is classified as a Class II device, with a regulation number of 864.8165. It is used in hematology and has a product code of KRZ.
Other devices from Alko Diagnostic Corp.
Questions
AI-generated answers, 22 Sep 2026
What is the Alko Slope Thb Solution used for?
The Alko Slope Thb Solution is used as a calibrator for hemoglobin and hematocrit measurement in the field of hematology.
Which analyzers is the Alko Slope Thb Solution compatible with?
The Alko Slope Thb Solution is designed for use with Corning 280, 288, and 2500 analyzers.
What is the regulatory classification of the Alko Slope Thb Solution?
The Alko Slope Thb Solution is classified as a Class II device with a regulation number of 864.8165.