FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
K Number: K862743
·
Decision Sep 29, 1986
Classifications
1
FEI Numbers
35
Registration Numbers
35
Same Product Code
31
Applicant Total
92
Review Days
70
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Basic Information
- Device Name
- PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUS
- K Number
- K862743
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3480
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- July 21, 1986
- Decision Date
- September 29, 1986
- Product Code
- GQG
- 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 |
|---|---|---|---|
| GQG | Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus | FDA class 1 | Microbiology |
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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 |
| 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 |
| K855013 | QUANTIMETRIC PLUS SUPPORT PACK | Feb 26, 1986 | Substantially Equivalent |