Coulochem II
FDA 510(k) K903231 · Esa, Inc.
510(k) numberK903231
Submission
- Device name
- Coulochem II
- Applicant
- Esa, Inc.
Bedford, MA, US - Received
- July 23, 1990
- Decision date
- September 27, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LEQ – Detectors, Electrochemical, Liquid Chromatography
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LEQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K962574 | Waters 474 Scanning Flourescence Detector (474)LEQ · Traditional | Waters Corporation | 07/22/1996SE |
| K864729 | Neurochemical AnalyzerLEQ · Traditional | Esa, Inc. | 04/13/1987SE |
| K801439 | Model 5100 Electrochemical DetectorLEQ · Traditional | Environmental Sciences Assoc., Inc. | 07/21/1980SE |
More from Environmental Sciences Assoc., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K032199 | Esa Plasma Free Metanephrine Analysis KitCHQ · Traditional | 01/30/2004SE |
| K971640 | Leadcare Blood Lead Testing SystemDOF · Traditional | 09/09/1997SE |
| K963938 | Model 5500 CeasCHQ · Traditional | 12/26/1996SE |
| K934977 | Model 5500 CeasCDF · Traditional | 01/11/1994SE |
| K931148 | Model 5500 Coulochem Electrode Array SystemCHQ · Traditional | 06/09/1993SE |
| K864729 | Neurochemical AnalyzerLEQ · Traditional | 04/13/1987SE |
Questions and answers
When was Coulochem II cleared by the FDA?
Coulochem II (K903231) received a 510(k) decision of Substantially Equivalent on September 27, 1990, 66 days after the submission was received.
What is the product code of K903231?
The FDA product code is LEQ – Detectors, Electrochemical, Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.