HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
FDA 510(k) clearance K972591 · decided 1998-03-04
Clearance details
- K-number
- K972591
- Device name
- HYDRAGEL BENCE JONES KIT/MAXI KIT HYDRAGEL BENCE JONES/HYDRAGEL 2/4 BENCE JONES KIT
- Applicant
- Morax
- Decision
- Substantially Equivalent
- Date received
- 1997-07-11
- Decision date
- 1998-03-04
- Days to decision
- 236 days
- Clearance type
- Traditional
- Product code
- JKM
- Device class
- 2
- Regulation number
- 866.5150
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Chelsea, MI, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
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| CAPILLARYS URINE (K080916) | Sebia | 2008-07-01 |
| CAPILLARYS URINE (PN 2012) (K070486) | Sebia, Inc. | 2007-12-21 |
| PARAGON CZE 2000 URINE PROTEIN ELECTROPHORESIS KIT AND URINE IMMUNOFIXATION BY SUBTRACTION KIT (K050119) | Beckman Coulter, Inc. | 2005-05-06 |
Recalls involving this device
No recalls on record reference this clearance.