FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
K Number: K854483
·
Decision Dec 11, 1985
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
1
Applicant Total
92
Review Days
34
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Basic Information
- Device Name
- KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KIT
- K Number
- K854483
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.5530
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- November 7, 1985
- Decision Date
- December 11, 1985
- Product Code
- KTO
- 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 |
|---|---|---|---|
| KTO | Reagent, Immunoassay, Igg | FDA class 1 | Immunology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KTO), ordered by most recent decision date.
View allOther 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 |