FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HEMACAL
K Number: K831306
·
Decision Jun 16, 1983
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
24
Applicant Total
14
Review Days
55
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Basic Information
- Device Name
- HEMACAL
- K Number
- K831306
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8165
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Hematology Marketing Assoc.
- Date Received
- April 22, 1983
- Decision Date
- June 16, 1983
- Product Code
- KRZ
- 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 |
|---|---|---|---|
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | FDA class 2 | Hematology |
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Other Clearances by Hematology Marketing Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K851843 | OSMOCEL 3 | Jul 30, 1985 | Substantially Equivalent |
| K851375 | TRI-COUNT | Jul 12, 1985 | Substantially Equivalent |
| K850096 | LASER-GLOBIN | Mar 29, 1985 | Substantially Equivalent |
| K850095 | LASER-DIL | Mar 29, 1985 | Substantially Equivalent |
| K850097 | LASER-LYSE | Mar 29, 1985 | Substantially Equivalent |
| K850094 | LASER-GLOBIN POWDER | Mar 29, 1985 | Substantially Equivalent |
| K844708 | TRI-COUNT CALIBRATOR | Mar 5, 1985 | Substantially Equivalent |
| K843485 | TRI-COUNT LASER | Dec 12, 1984 | Substantially Equivalent |
| K834371 | TRI-COUNT 10 | Mar 9, 1984 | Substantially Equivalent |
| K833130 | TRI-COUNT 7 | Oct 20, 1983 | Substantially Equivalent |