WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
FDA 510(k) clearance K962574 · decided 1996-07-22
Clearance details
- K-number
- K962574
- Device name
- WATERS 474 SCANNING FLOURESCENCE DETECTOR (474)
- Applicant
- Waters Corporation
- Decision
- Substantially Equivalent
- Date received
- 1996-07-01
- Decision date
- 1996-07-22
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- LEQ
- Device class
- 1
- Regulation number
- 862.2260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Milford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| COULOCHEM II (K903231) | Esa, Inc. | 1990-09-27 |
| NEUROCHEMICAL ANALYZER (K864729) | Esa, Inc. | 1987-04-13 |
| MODEL 5100 ELECTROCHEMICAL DETECTOR (K801439) | Environmental Sciences Assoc., Inc. | 1980-07-21 |
Recalls involving this device
No recalls on record reference this clearance.