FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ADENOVIRUS GROUP-FA LABELLED PRESERUM
K Number: K770811
·
Decision May 20, 1977
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
3
Applicant Total
57
Review Days
17
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Basic Information
- Device Name
- ADENOVIRUS GROUP-FA LABELLED PRESERUM
- K Number
- K770811
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3020
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Flow Laboratories, Inc.
- Date Received
- May 3, 1977
- Decision Date
- May 20, 1977
- Product Code
- GNY
- Advisory Committee
- Microbiology
- 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 |
|---|---|---|---|
| GNY | Antisera, Fluorescent, Adenovirus 1-33 | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNY), ordered by most recent decision date.
RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY
FDA 510(k)
FDA Class 1
·Microbiology
MURINE MONOCLONAL ANTI-ADENOVIRUS IGG
FDA 510(k)
FDA Class 1
·Microbiology
ADENOVIRUS-GROUP FA LABELLED (8-651 RF)
FDA 510(k)
FDA Class 1
·Microbiology
Other Clearances by Flow Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K861897 | UNISKAN II | Jul 1, 1986 | Substantially Equivalent |
| K862066 | TITERTEK MICROPLATE WASHER S-12 | Jun 5, 1986 | Substantially Equivalent |
| K861823 | GENTAMICIN SULFATE SOLUTION (50MG GENTAMICIN) | May 20, 1986 | Substantially Equivalent |
| K861824 | GENTAMICIN SULFATE SOLUTION (10MG GENTAMICIN) | May 20, 1986 | Substantially Equivalent |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | May 20, 1986 | Substantially Equivalent |
| K860752 | GOAT SERUM (29-391-54) | Mar 10, 1986 | Substantially Equivalent |
| K860762 | GAMMA-FREE HORSE SERUM | Mar 10, 1986 | Substantially Equivalent |
| K850908 | TITERTEK MICROITTRATION EQUIP. HANDIWASH 110 12CHA | Mar 25, 1985 | Substantially Equivalent |
| K844418 | TITERTEK MULTISKAN MCC | Mar 21, 1985 | Substantially Equivalent |
| K844419 | TITERTEK MULTISKAN MSS/340 | Mar 21, 1985 | Substantially Equivalent |