FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CITRATE BUFFER
K Number: K811251
·
Decision May 21, 1981
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
6
Applicant Total
16
Review Days
16
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Basic Information
- Device Name
- CITRATE BUFFER
- K Number
- K811251
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Bioscientific
- Date Received
- May 5, 1981
- Decision Date
- May 21, 1981
- Product Code
- JCC
- Advisory Committee
- Pathology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JCC | Ph Buffer | FDA class 1 | Pathology |
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Other Clearances by Bioscientific
| K Number | Device Name | ||
|---|---|---|---|
| K812447 | AMYLASE REAGENT KIT | Sep 9, 1981 | Substantially Equivalent |
| K801267 | RED BLOOD CELL COUNT & HEMATOCRIT CNTL | Jul 14, 1980 | 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 |