Hemoglobin Reagent Set
510(k) K860475
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK860475 | Date3 Mar 1986 | StatusActive |
Official records
- FDA 510(k) database K860475
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- KHG
- FDA applicant
- Sterling Diagnostics, Inc.
- Device class
- Class II
- Regulation
- 21 CFR Part 864.7500
- Advisory committee
- Hematology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 25 Sep 2026
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.
Similar devices
Other devices filed under FDA product code KHG (Whole Blood Hemoglobin Determination).
- STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090 by Gds Technology, LLC
- Vision Hemoglobin by Abbott Laboratories
- REFLOTRON HEMOGLOBIN TEST TABS by Boehringer Mannheim Corp.
- COMPUR M-1000 MINI-PHOTOMETER by Miles Laboratories, Inc.
- CARESIDE HEMOGLOBIN by Careside, Inc.
- CYANMETHEMOGLOBIN TEST by Boehringer Mannheim Corp.
- HEMOGLOBIN by POINTE SCIENTIFIC, INC.
- AMES SERA-PAK HEMOGLOBIN REAGENT by Miles Laboratories, Inc.
- TOTAL HEMOGLOBIN by J. D. Assoc.
- SANDARE CYANMETHEMOGLOBIN REAGENT by Sandare Chemical Co., Inc.