FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
QUANTIMETRIC 2 TEST KIT
K Number: K813242
·
Decision Dec 2, 1981
Classifications
1
FEI Numbers
105
Registration Numbers
105
Same Product Code
7
Applicant Total
92
Review Days
15
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Basic Information
- Device Name
- QUANTIMETRIC 2 TEST KIT
- K Number
- K813242
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 864.3010
- Medical Specialty
- Pathology
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- November 17, 1981
- Decision Date
- December 2, 1981
- Product Code
- KEW
- Advisory Committee
- Pathology
- 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 |
|---|---|---|---|
| KEW | Slides, Microscope | FDA class 1 | Pathology |
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Other Clearances by Kallestad Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K863681 | PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEM | Dec 3, 1986 | Substantially Equivalent |
| K862917 | PATHFINDER ROTAVIRUS CHEMILUMINESCENT | Oct 22, 1986 | Substantially Equivalent |
| K863682 | PATHFINDER(TM) SPECIMEN COLLECTION KIT | Oct 10, 1986 | Substantially Equivalent |
| K862743 | PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS | Sep 29, 1986 | Substantially Equivalent |
| K862313 | KALLESTAD SM/RNP TEST REAGENT | Aug 6, 1986 | Substantially Equivalent |
| K862710 | KALLESTAD SSA/SSB ENA TEST REAGENTS | Jul 29, 1986 | Substantially Equivalent |
| K855014 | QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET A | Mar 14, 1986 | Substantially Equivalent |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Feb 28, 1986 | Substantially Equivalent |
| K855009 | QUANTIMETRIC PLUS IGA REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |
| K855008 | QUANTIMETRIC PLUS KAPPA REAGENT KIT | Feb 26, 1986 | Substantially Equivalent |