FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MODIFIED EA 50
K Number: K820027
·
Decision Feb 4, 1982
Classifications
1
FEI Numbers
30
Registration Numbers
30
Same Product Code
14
Applicant Total
12
Review Days
30
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Basic Information
- Device Name
- MODIFIED EA 50
- K Number
- K820027
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Surgipath
- Date Received
- January 5, 1982
- Decision Date
- February 4, 1982
- Product Code
- HZJ
- Advisory Committee
- Hematology
- Review Advisory Committee
- PA
- 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 |
|---|---|---|---|
| HZJ | Stain, Papanicolau | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HZJ), ordered by most recent decision date.
GILL PAPANICOLAOU STAIN EA-1 & 2 OG-6
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FDA Class 1
·Hematology
PAP STAIN, EA-36
FDA 510(k)
FDA Class 1
·Hematology
PAP STAIN EA-65
FDA 510(k)
FDA Class 1
·Hematology
PAP STAIN EA-50
FDA 510(k)
FDA Class 1
·Hematology
PAP STAIN, OG-6
FDA 510(k)
FDA Class 1
·Hematology
PAPANICOLAOU STAIN SYS HT40
FDA 510(k)
FDA Class 1
·Hematology
Other Clearances by Surgipath
| K Number | Device Name | ||
|---|---|---|---|
| K812940 | 10% NEUTRAL BUFFERED FORMALIN CONCENT | Dec 10, 1981 | Substantially Equivalent |
| K812087 | EA 50 | Aug 13, 1981 | Substantially Equivalent |
| K812086 | EA 65 | Aug 13, 1981 | Substantially Equivalent |
| K811825 | ORANGE G-6 | Jul 10, 1981 | Substantially Equivalent |
| K811826 | EOSIN Y | Jul 10, 1981 | Substantially Equivalent |
| K810836 | DECALCIFIER II | Apr 23, 1981 | Substantially Equivalent |
| K810758 | GILL'S HEMATOXYLIN #1 | Apr 14, 1981 | Substantially Equivalent |
| K810733 | HARRIS HEMATOXYLIN | Apr 14, 1981 | Substantially Equivalent |
| K810759 | GILL'S HEMATOXYLIN #2 | Apr 14, 1981 | Substantially Equivalent |
| K810760 | GILL'S HEMATOXYLIN #3 | Apr 14, 1981 | Substantially Equivalent |