FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CYANOMETHEMOGLOBIN REAGENT
K Number: K841799
·
Decision May 31, 1984
Classifications
1
FEI Numbers
54
Registration Numbers
54
Same Product Code
37
Applicant Total
19
Review Days
43
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Basic Information
- Device Name
- CYANOMETHEMOGLOBIN REAGENT
- K Number
- K841799
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.8200
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Reagent Laboratory, Inc.
- Date Received
- April 18, 1984
- Decision Date
- May 31, 1984
- Product Code
- GIF
- 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 |
|---|---|---|---|
| GIF | Diluent, Blood Cell | FDA class 1 | Hematology |
Similar 510(k) Clearances
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CELL-DYN DIFF. SCREEN ISOTONIC DILUENT
FDA 510(k)
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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 |
| K863503 | HEMOLYSE | Oct 3, 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 |
| K841800 | LYSING & HEMOGLOBIN REAGENT | May 31, 1984 | Substantially Equivalent |