Model 5500 Coulochem Electrode Array System
FDA 510(k) K931148 · Esa, Inc.
510(k) numberK931148
Submission
- Device name
- Model 5500 Coulochem Electrode Array System
- Applicant
- Esa, Inc.
Bedford, MA, US - Received
- March 5, 1993
- Decision date
- June 9, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CHQ – Chromatographic/Fluorometric Method, Catecholamines
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1165
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CHQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051969 | Tricat Ria (Adrenalin/Noradrenalin/Dopamine); Katcombi Ria (Adrenalin/Noradrenalin)…CHQ · Traditional | Ibl GmbH | 10/03/2005SE |
| K032199 | Esa Plasma Free Metanephrine Analysis KitCHQ · Traditional | Esa, Inc. | 01/30/2004SE |
| K972167 | Plasma Catecholamine KitCHQ · Traditional | Bioanalytical Systems, Inc. | 08/04/1997SE |
| K963938 | Model 5500 CeasCHQ · Traditional | Esa, Inc. | 12/26/1996SE |
| K952919 | Urinary Metanephrine KitCHQ · Traditional | Bioanalytical Systems, Inc. | 09/06/1995SE |
| K943099 | Urinary Catecholamine KitCHQ · Traditional | Bioanalytical Systems, Inc. | 10/07/1994SE |
| K894966 | Plasma Catecholamines by HPLCCHQ · Traditional | Bio-Rad | 10/25/1989SE |
| K873371 | Urinary Free Catecholamines & Metanephrines (HPLC)CHQ · Traditional | Bio-Rad | 01/05/1988SE |
| K855214 | CAT-3 Catecholamine Assay KitCHQ · Traditional | Whale Scientific, Inc. | 03/14/1986SE |
More from Whale Scientific, 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 |
| K903231 | Coulochem IILEQ · Traditional | 09/27/1990SE |
| K864729 | Neurochemical AnalyzerLEQ · Traditional | 04/13/1987SE |
Questions and answers
When was Model 5500 Coulochem Electrode Array System cleared by the FDA?
Model 5500 Coulochem Electrode Array System (K931148) received a 510(k) decision of Substantially Equivalent on June 9, 1993, 96 days after the submission was received.
What is the product code of K931148?
The FDA product code is CHQ – Chromatographic/Fluorometric Method, Catecholamines, a Class I (low risk) device regulated under 21 CFR 862.1165.