FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
K Number: K791455
·
Decision Dec 31, 1979
Classifications
1
FEI Numbers
26
Registration Numbers
26
Same Product Code
58
Applicant Total
66
Review Days
147
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Basic Information
- Device Name
- AGGLUTINOTEST-INFECTIOUS MONONUCLEOSIS
- K Number
- K791455
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.5640
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Volu Sol Medical Industries
- Date Received
- August 6, 1979
- Decision Date
- December 31, 1979
- Product Code
- KTN
- Advisory Committee
- Immunology
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| KTN | System, Test, Infectious Mononucleosis | FDA class 2 | Immunology |
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Other Clearances by Volu Sol Medical Industries
| K Number | Device Name | ||
|---|---|---|---|
| K822126 | VOLU-SOL CARNOY FLUID | Aug 5, 1982 | Substantially Equivalent |
| K822128 | VOLU-SOL SINGLE DIFFERENTIAL STAIN | Aug 5, 1982 | Substantially Equivalent |
| K822127 | VOLU-SOL ZENKERS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822129 | VOLU-SOL BOVINS FIXATIVE | Aug 5, 1982 | Substantially Equivalent |
| K822036 | VOLU-SOL DECALCIFER | Aug 3, 1982 | Substantially Equivalent |
| K822035 | VOLU-SOL GILLS EA | Aug 3, 1982 | Substantially Equivalent |
| K822038 | VOLU-SOL ORANGE G-6(GILLS-MOD | Aug 3, 1982 | Substantially Equivalent |
| K822037 | VOLU-SOL TAP WATER SUBSTITUTE | Aug 3, 1982 | Substantially Equivalent |
| K812906 | ELVI BICLOT 816 | Jul 22, 1982 | Substantially Equivalent |
| K821541 | HEMATOXYLIN III | Jun 10, 1982 | Substantially Equivalent |