FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
K Number: K962574
·
Decision Jul 22, 1996
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
6
Review Days
21
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Basic Information
- Device Name
- WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
- K Number
- K962574
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2260
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Waters Corporation
- Date Received
- July 1, 1996
- Decision Date
- July 22, 1996
- Product Code
- LEQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| LEQ | Detectors, Electrochemical, Liquid Chromatography | FDA class 1 | Clinical Chemistry |
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Other Clearances by Waters Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K063868 | MASSTRAK IMMUNOSUPPRESSANTS KIT | May 25, 2007 | Substantially Equivalent |
| K980180 | 2700 SAMPLE MANAGER | Feb 12, 1998 | Substantially Equivalent |
| K973074 | 2487 DUAL WAVELENGTH ABSORBANCE DETECTOR | Oct 6, 1997 | Substantially Equivalent |
| K964588 | WATERS 515 HPLC PUMP (515) | Nov 29, 1996 | Substantially Equivalent |
| K961557 | ALLIANCE 2690 SEPARATIONS MODULE | Jul 5, 1996 | Substantially Equivalent |