FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
UNISKAN II
K Number: K861897
·
Decision Jul 1, 1986
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
57
Review Days
46
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Basic Information
- Device Name
- UNISKAN II
- K Number
- K861897
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Flow Laboratories, Inc.
- Date Received
- May 16, 1986
- Decision Date
- July 1, 1986
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Flow Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K844567 | TITERTEK TWINREADER 78-630-00 | Mar 21, 1985 | Substantially Equivalent |