Plasma Catecholamines by HPLC
FDA 510(k) K894966 · Bio-Rad
510(k) numberK894966
Submission
- Device name
- Plasma Catecholamines by HPLC
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- August 7, 1989
- Decision date
- October 25, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K931148 | Model 5500 Coulochem Electrode Array SystemCHQ · Traditional | Esa, Inc. | 06/09/1993SE |
| 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 |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Plasma Catecholamines by HPLC cleared by the FDA?
Plasma Catecholamines by HPLC (K894966) received a 510(k) decision of Substantially Equivalent on October 25, 1989, 79 days after the submission was received.
What is the product code of K894966?
The FDA product code is CHQ – Chromatographic/Fluorometric Method, Catecholamines, a Class I (low risk) device regulated under 21 CFR 862.1165.