FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEISSERIA-KWIK
K Number: K811412
·
Decision Jun 16, 1981
Classifications
1
FEI Numbers
6
Registration Numbers
6
Same Product Code
15
Applicant Total
19
Review Days
28
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Basic Information
- Device Name
- NEISSERIA-KWIK
- K Number
- K811412
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Windsor Laboratories, Inc.
- Date Received
- May 19, 1981
- Decision Date
- June 16, 1981
- Product Code
- JSX
- Advisory Committee
- Microbiology
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JSX | Kit, Identification, Neisseria Gonorrhoeae | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JSX), ordered by most recent decision date.
GONOPOX TEST KIT
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NIZYME TEST KIT
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XACT NEISSERIA
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MODIFIED IDS RAPID NH SYSTEM
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NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST
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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 |
| K862248 | AMIKACIN KIT (FPIA) | Aug 4, 1986 | Substantially Equivalent |
| K861770 | PHENYTOIN (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |