FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
K Number: K811445
·
Decision Jun 24, 1981
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
92
Review Days
33
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Basic Information
- Device Name
- KALLESTAD R QUANTIPLATE ALT. PATHWAY T.
- K Number
- K811445
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.4100
- Medical Specialty
- Immunology
- Decision
- Substantially Equivalent
- Applicant
- Kallestad Laboratories, Inc.
- Date Received
- May 22, 1981
- Decision Date
- June 24, 1981
- Product Code
- DHL
- 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 |
|---|---|---|---|
| DHL | Protein, Complement, Antigen, Antiserum, Control | FDA class 1 | Immunology |
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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 |