FDA 510(k)
Substantially Equivalent
🇺🇸 United States
WRIGHT STAIN PACK
K Number: K791658
·
Decision Oct 17, 1979
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
16
Review Days
57
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Basic Information
- Device Name
- WRIGHT STAIN PACK
- K Number
- K791658
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- Bioscientific
- Date Received
- August 21, 1979
- Decision Date
- October 17, 1979
- Advisory Committee
- Unknown
- Review Advisory Committee
- HE
- Third Party
- N
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 |
| 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 |
| 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 |