FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AGGLUTINOTEST-STAPHYLOLISIN
K Number: K791453
·
Decision Sep 24, 1979
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
3
Applicant Total
66
Review Days
49
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Basic Information
- Device Name
- AGGLUTINOTEST-STAPHYLOLISIN
- K Number
- K791453
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Volu Sol Medical Industries
- Date Received
- August 6, 1979
- Decision Date
- September 24, 1979
- Product Code
- GTN
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| GTN | Antisera, Fluorescent, All Types, Staphylococcus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GTN), ordered by most recent decision date.
DIAGNOSTIC REAGENT TST-RPLA
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FDA Class 1
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DIAGNOSTIC REAGENT SET-RPLA
FDA 510(k)
FDA Class 1
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STAPHAUREX ZL30
FDA 510(k)
FDA Class 1
·Microbiology
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 |