510(k) K894966
- Device
- PLASMA CATECHOLAMINES BY HPLC
- Applicant
- BIO-RAD
- 510(k) number
- K894966
- Product code
- CHQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-10-25
- Date received
- 1989-08-07
- Regulation
- 862.1165
- Classification name
- Chromatographic/fluorometric Method, Catecholamines
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- LYNN C SHANTA
- Address
- 4000 Alfred Nobel Dr. Hercules CA US 94547 94547
FDA Registration Numbers#
- 3003951180
- 2915274
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CHQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA | Ibl GmbH | 2005-10-03 |
| K032199 | ESA PLASMA FREE METANEPHRINE ANALYSIS KIT | Esa, Inc. | 2004-01-30 |
| K972167 | PLASMA CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | 1997-08-04 |
| K963938 | MODEL 5500 CEAS | Esa, Inc. | 1996-12-26 |
| K952919 | URINARY METANEPHRINE KIT | Bioanalytical Systems, Inc. | 1995-09-06 |
| K943099 | URINARY CATECHOLAMINE KIT | Bioanalytical Systems, Inc. | 1994-10-07 |
| K931148 | MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM | Esa, Inc. | 1993-06-09 |
| K873371 | URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) | Bio-Rad | 1988-01-05 |
| K855214 | CAT-3 CATECHOLAMINE ASSAY KIT | Whale Scientific, Inc. | 1986-03-14 |
Legacy Summary#
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FDA Review#
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