FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
FLUOROSKAN
K Number: K842049
·
Decision Dec 3, 1984
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
13
Applicant Total
57
Review Days
195
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Basic Information
- Device Name
- FLUOROSKAN
- K Number
- K842049
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4520
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Flow Laboratories, Inc.
- Date Received
- May 22, 1984
- Decision Date
- December 3, 1984
- Product Code
- JZT
- 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 |
|---|---|---|---|
| JZT | Fluorometer | FDA class 1 | Immunology |
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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 |
| 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 |