FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMIKACIN KIT (FPIA)
K Number: K862248
·
Decision Aug 4, 1986
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
19
Review Days
53
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Basic Information
- Device Name
- AMIKACIN KIT (FPIA)
- K Number
- K862248
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3035
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Windsor Laboratories, Inc.
- Date Received
- June 12, 1986
- Decision Date
- August 4, 1986
- Product Code
- LGJ
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- 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 |
|---|---|---|---|
| LGJ | Fluorescence Polarization Immunoassay, Amibacin | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LGJ), ordered by most recent decision date.
COBAS INTEGRA AMIKACIN MAB
FDA 510(k)
FDA Class 2
·Clinical Toxicology
COBAS-FP REAGENTS AND CALIBRATORS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
Other Clearances by Windsor Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873281 | CARBAMAZEPINE (FPIA) CALIBRATOR KIT | Oct 28, 1987 | Substantially Equivalent |
| K873282 | CARBAMAZEPINE FPIA FLUORES. POLARIZA. IMMUNOASSAY | Sep 22, 1987 | Substantially Equivalent |
| K871486 | (FPIA) ASSAY BUFFER | May 8, 1987 | Substantially Equivalent |
| K870389 | DIGOXIN (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K870390 | PHENOBARBITAL (FPIA) CALIBRATOR KIT | Apr 1, 1987 | Substantially Equivalent |
| K864333 | DIGOXIN FPIA FLUORESCENCE POLARIZATION IMMUNOASSAY | Jan 5, 1987 | Substantially Equivalent |
| K863625 | PHENOBARBITAL-FPIA FLUORES. POLAR. IMMUNOASSAY KIT | Nov 10, 1986 | Substantially Equivalent |
| K863244 | AMIKACIN (FPIA) CALIBRATOR KIT | Aug 29, 1986 | Substantially Equivalent |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |