FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RED BLOOD CELL COUNT & HEMATOCRIT CNTL
K Number: K801267
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
191
Applicant Total
16
Review Days
47
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Basic Information
- Device Name
- RED BLOOD CELL COUNT & HEMATOCRIT CNTL
- K Number
- K801267
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.8625
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bioscientific
- Date Received
- May 28, 1980
- Decision Date
- July 14, 1980
- Product Code
- JPK
- 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 |
|---|---|---|---|
| JPK | Mixture, Hematology Quality Control | FDA class 2 | Hematology |
Similar 510(k) Clearances
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Other Clearances by Bioscientific
| K Number | Device Name | ||
|---|---|---|---|
| K812447 | AMYLASE REAGENT KIT | Sep 9, 1981 | Substantially Equivalent |
| K811251 | CITRATE BUFFER | May 21, 1981 | Substantially Equivalent |
| K801265 | WHITE BLOOD CELL COUNT CONTROL LEVELS | Jul 14, 1980 | Substantially Equivalent |
| K801268 | HEMOGLOBIN CONTROL LEVELS | Jul 14, 1980 | Substantially Equivalent |
| K791658 | WRIGHT STAIN PACK | Oct 17, 1979 | Substantially Equivalent |
| K791007 | STAT DIFF STAIN | Aug 3, 1979 | Substantially Equivalent |
| K790415 | HCP-7 | Apr 4, 1979 | Substantially Equivalent |
| K781734 | SODIUM CHLORIDE, 0.85% | Oct 24, 1978 | Substantially Equivalent |
| K781588 | PAPANICOLAOU STIAN OG-6 | Oct 10, 1978 | Substantially Equivalent |
| K781587 | HEMATOLOGY STAIN PACK | Oct 10, 1978 | Substantially Equivalent |