FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HEMATOLOGY WRIGHT'S STAIN PACK
K Number: K833678
·
Decision Nov 25, 1983
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
32
Applicant Total
18
Review Days
38
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Basic Information
- Device Name
- HEMATOLOGY WRIGHT'S STAIN PACK
- K Number
- K833678
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- J.S. Medical Assoc.
- Date Received
- October 18, 1983
- Decision Date
- November 25, 1983
- Product Code
- IAF
- 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 |
|---|---|---|---|
| IAF | Wright'S Stain | FDA class 1 | Hematology |
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Other Clearances by J.S. Medical Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K932752 | VISI-SPOT | Nov 5, 1993 | Substantially Equivalent |
| K932688 | EYE SPOT IM TEST | Sep 8, 1993 | Substantially Equivalent |
| K932180 | EYE SPOT CRP TEST | Aug 23, 1993 | Substantially Equivalent |
| K932551 | ACCUTEX IM LATEX TEST | Aug 9, 1993 | Substantially Equivalent |
| K926112 | ACCUTEX BETA-HCG TEST | Jul 28, 1993 | Substantially Equivalent |
| K924332 | ACCUTEX CRP LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924247 | ACCUTEX ASO LATEX TEST | Dec 7, 1992 | Substantially Equivalent |
| K924036 | ACCUTEX RHEUMATIOD FACTOR (RF) LATEX TEST | Dec 1, 1992 | Substantially Equivalent |
| K924037 | ACCUTEX IM RBC TEST | Nov 2, 1992 | Substantially Equivalent |
| K924248 | ACCUTEX SLE LATEX TEST | Nov 2, 1992 | Substantially Equivalent |