Identifiers
- 510(k) Number
- K860475 FDA 510(k)
- FDA Product Code
- KHG FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 864.7500 FDA 510(k)
- Regulation Number
- 864.7500 FDA 510(k)
- Advisory Committee
- Hematology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hemoglobin Reagent Set is a device used for whole blood hemoglobin determination. It is classified under product code KHG and falls within the hematology medical specialty.
This reagent set received FDA 510(k) clearance (K860475) on March 3, 1986, as a substantially equivalent device under traditional review. It is a Class II device subject to special controls and was submitted by Sterling Diagnostics, Inc. of Sterling Heights, Michigan.
Frequently asked questions
What is the Hemoglobin Reagent Set used for?
The Hemoglobin Reagent Set is used for whole blood hemoglobin determination, as stated in the device description and confirmed by its classification under product code KHG and medical specialty hematology.
How was the Hemoglobin Reagent Set authorized for market?
The Hemoglobin Reagent Set received FDA 510(k) clearance (K860475) on March 3, 1986, through a traditional review process, demonstrating substantial equivalence to a legally marketed predicate device.
What regulatory class and controls apply to the Hemoglobin Reagent Set?
The Hemoglobin Reagent Set is classified as a Class II device and is subject to special controls, as indicated by its FDA 510(k) clearance and device class designation in the openfda field.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HEMOGLOBIN REAGENT SET (K860475) — FDA 510 (k) | Innolitics, Home [www.sterlingdiagnostics.com], K860475 FDA 510 (k) - HEMOGLOBIN REAGENT SET, HEMOGLOBIN REAGENT SET 510 (k) K860475 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K860475 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sterling Diagnostics Inc
- FDA Applicant
- Sterling Diagnostics, Inc.
Sources (1)
- FDA 510(k) K860475 24 fields · synced Sep 25, 2026