FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
INFLUENZA HI ANTISERUM A/TEXAS
K Number: K780276
·
Decision Feb 28, 1978
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
8
Applicant Total
57
Review Days
11
Basic Information
- Device Name
- INFLUENZA HI ANTISERUM A/TEXAS
- K Number
- K780276
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3330
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- FLOW LABORATORIES, INC.
- Date Received
- February 17, 1978
- Decision Date
- February 28, 1978
- Product Code
- GNS
- 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 |
|---|---|---|---|
| GNS | Antisera, Hai, Influenza Virus A, B, C | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GNS), ordered by most recent decision date.
GOAT ANTI-INFLUENZA ANTISERA ATEXAS
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INFLUENZA HI ANTISERUM
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INFLUENZA HI PRESERUM A/TEXAS
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GOAT ANTI-INFLUENZA ANTISERA
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FDA Class 1
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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 |
| K861791 | PENICILLIN-STREPTOMYCIN-FUNGIZONE | May 20, 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 |
| 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 |