FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACRIDINE ORANGE STAIN
K Number: K810040
·
Decision Feb 12, 1981
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
3
Applicant Total
632
Review Days
34
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Basic Information
- Device Name
- ACRIDINE ORANGE STAIN
- K Number
- K810040
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.1850
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- January 9, 1981
- Decision Date
- February 12, 1981
- Product Code
- IDC
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| IDC | Acridine Orange | FDA class 1 | Hematology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (IDC), ordered by most recent decision date.
ACRIDINE ORANGE FLUORESCENT STAIN
FDA 510(k)
FDA Class 1
·Hematology
ACRIDINE ORANGE STAIN
FDA 510(k)
FDA Class 1
·Hematology
ACRIDINE ORANGE STAIN
FDA 510(k)
FDA Class 1
·Hematology
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| K993186 | SYNERCID, 15 UG, BBL SENSI-DISC | Nov 3, 1999 | Substantially Equivalent |
| K992734 | BECTON DICKINSON SYRINGE | Oct 1, 1999 | Substantially Equivalent |
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