COULOCHEM II
FDA 510(k) clearance K903231 · decided 1990-09-27
Clearance details
- K-number
- K903231
- Device name
- COULOCHEM II
- Applicant
- Esa, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-07-23
- Decision date
- 1990-09-27
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- LEQ
- Device class
- 1
- Regulation number
- 862.2260
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bedford, 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 |
|---|---|---|
| WATERS 474 SCANNING FLOURESCENCE DETECTOR (474) (K962574) | Waters Corporation | 1996-07-22 |
| 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.