URINARY METANEPHRINE KIT
FDA 510(k) clearance K952919 · decided 1995-09-06
Clearance details
- K-number
- K952919
- Device name
- URINARY METANEPHRINE KIT
- Applicant
- Bioanalytical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-06-26
- Decision date
- 1995-09-06
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- CHQ
- Device class
- 1
- Regulation number
- 862.1165
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Lafayette, IN, 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 |
|---|---|---|
| TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA (ADRENALIN/NORADRENALIN); NORADRENALIN RIA (K051969) | Ibl GmbH | 2005-10-03 |
| ESA PLASMA FREE METANEPHRINE ANALYSIS KIT (K032199) | Esa, Inc. | 2004-01-30 |
| PLASMA CATECHOLAMINE KIT (K972167) | Bioanalytical Systems, Inc. | 1997-08-04 |
| MODEL 5500 CEAS (K963938) | Esa, Inc. | 1996-12-26 |
| URINARY CATECHOLAMINE KIT (K943099) | Bioanalytical Systems, Inc. | 1994-10-07 |
| MODEL 5500 COULOCHEM ELECTRODE ARRAY SYSTEM (K931148) | Esa, Inc. | 1993-06-09 |
| PLASMA CATECHOLAMINES BY HPLC (K894966) | Bio-Rad | 1989-10-25 |
| URINARY FREE CATECHOLAMINES & METANEPHRINES (HPLC) (K873371) | Bio-Rad | 1988-01-05 |
| CAT-3 CATECHOLAMINE ASSAY KIT (K855214) | Whale Scientific, Inc. | 1986-03-14 |
Recalls involving this device
No recalls on record reference this clearance.