FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY ANALYZER
K Number: K842310
·
Decision Sep 6, 1984
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
3
Review Days
86
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Basic Information
- Device Name
- HEMATOLOGY ANALYZER
- K Number
- K842310
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1060
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hml Inc/Biotechnology Transfer
- Date Received
- June 12, 1984
- Decision Date
- September 6, 1984
- Product Code
- JKL
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JKL | Acid, Delta-Aminolevulinic, Ion-Exchange Columns With Colorimetry | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JKL), ordered by most recent decision date.
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