FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMOLYSE
K Number: K863503
·
Decision Oct 3, 1986
Classifications
1
FEI Numbers
50
Registration Numbers
50
Same Product Code
28
Applicant Total
19
Review Days
24
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
- HEMOLYSE
- K Number
- K863503
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8540
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Reagent Laboratory, Inc.
- Date Received
- September 9, 1986
- Decision Date
- October 3, 1986
- Product Code
- GGK
- 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 |
|---|---|---|---|
| GGK | Products, Red-Cell Lysing Products | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GGK), ordered by most recent decision date.
COULTER CLONE QUICK STAIN WHOLE BLOOD LYSE-II
FDA 510(k)
FDA Class 1
·Hematology
KVM HEMOGLOBIN LYSING REAGENT
FDA 510(k)
FDA Class 1
·Hematology
FISHER DIAGNOSTICS HEMATALL III LAS REAGENT
FDA 510(k)
FDA Class 1
·Hematology
CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG.
FDA 510(k)
FDA Class 1
·Hematology
PIASTRINIT
FDA 510(k)
FDA Class 1
·Hematology
NSI LYSING-D REAGENT -4000 ML
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Reagent Laboratory, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863502 | SOLUTION B- NA 50MEQ/L, K 40 MEQ/L | Oct 21, 1986 | Substantially Equivalent |
| K863550 | POTASSIUM HYDROXIDE 10% W/V | Oct 2, 1986 | Substantially Equivalent |
| K860143 | URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE | Feb 10, 1986 | Substantially Equivalent |
| K842982 | FORMALIN BUFFERED | Oct 1, 1984 | Substantially Equivalent |
| K843050 | GRAM STAIN | Sep 11, 1984 | Substantially Equivalent |
| K842785 | STAIN, METHYLENE BLUE-EOSIN | Sep 11, 1984 | Substantially Equivalent |
| K841847 | LITHIUM REAGENT | Aug 17, 1984 | Substantially Equivalent |
| K843051 | WRIGHTS STAIN SOLUTION | Aug 3, 1984 | Unknown |
| K841799 | CYANOMETHEMOGLOBIN REAGENT | May 31, 1984 | Substantially Equivalent |
| K841800 | LYSING & HEMOGLOBIN REAGENT | May 31, 1984 | Substantially Equivalent |