FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
(FPIA) ASSAY BUFFER
K Number: K871486
·
Decision May 8, 1987
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
19
Review Days
23
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Basic Information
- Device Name
- (FPIA) ASSAY BUFFER
- K Number
- K871486
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Windsor Laboratories, Inc.
- Date Received
- April 15, 1987
- Decision Date
- May 8, 1987
- Product Code
- JJF
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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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 |
| 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 |
| K861768 | THEOPHYLLINE (FPIA) CALIBRATOR KIT | Jun 25, 1986 | Substantially Equivalent |