FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VISION(TM) HEMOGLOBIN
K Number: K862202
·
Decision Aug 18, 1986
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
38
Applicant Total
883
Review Days
69
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- VISION(TM) HEMOGLOBIN
- K Number
- K862202
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.7500
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- June 10, 1986
- Decision Date
- August 18, 1986
- Product Code
- KHG
- Advisory Committee
- Hematology
- Review Advisory Committee
- HE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHG | Whole Blood Hemoglobin Determination | FDA class 2 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHG), ordered by most recent decision date.
AnemoCheck Home
FDA 510(k)
FDA Class 2
·Hematology
AnemoCheck
FDA 510(k)
FDA Class 2
·Hematology
ANEMIAPRO SELF-SCREENER
FDA 510(k)
FDA Class 2
·Hematology
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
FDA 510(k)
FDA Class 2
·Hematology
CARESIDE HEMOGLOBIN
FDA 510(k)
FDA Class 2
·Hematology
HEMOSITE TEST SYSTEM
FDA 510(k)
FDA Class 2
·Hematology
Other Clearances by Abbott Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K252424 | Anti-HCV Next | Apr 28, 2026 | Substantially Equivalent |
| K243500 | ARCHITECT iGentamicin | Jul 9, 2025 | Substantially Equivalent |
| K243168 | Alinity i Rubella IgG | Jun 20, 2025 | Substantially Equivalent |
| K243283 | Alinity h-series System | Feb 20, 2025 | Substantially Equivalent |
| K233932 | Alinity i Toxo IgM | Aug 30, 2024 | Substantially Equivalent |
| K232669 | TBI | Sep 29, 2023 | Substantially Equivalent |
| K222850 | HAVAb IgG II | Aug 10, 2023 | Substantially Equivalent |
| K220031 | Alinity h-series System | Aug 4, 2023 | Substantially Equivalent |
| K220282 | i-STAT PTplus Cartridge with the i-STAT 1 System | Jul 14, 2023 | Substantially Equivalent |
| K230937 | Alinity i Total ß-hCG Reagent Kit, GLP systems Track | Jun 5, 2023 | Substantially Equivalent |