BILIRUBIN ASSAY ON THE OMNI S ANALYZER
FDA 510(k) clearance K040174 · decided 2004-05-14
Clearance details
- K-number
- K040174
- Device name
- BILIRUBIN ASSAY ON THE OMNI S ANALYZER
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-26
- Decision date
- 2004-05-14
- Days to decision
- 109 days
- Clearance type
- Traditional
- Product code
- MQM
- Device class
- 1
- Regulation number
- 862.1113
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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| JAUNDICE METER, MODEL JM 103 (K042522) | Draeger Medical Infant Care, Inc. | 2005-07-06 |
| HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103 (K021622) | Hill-Rom Air-Shields | 2003-04-01 |
| COLORMATE TLC BILITEST SYSTEM (K001687) | Chromatics Color Sciences Intl., Inc. | 2001-09-13 |
| RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANALYZER (K010052) | Respironics, Inc. | 2001-03-19 |
| BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K994438) | Spectrx, Inc. | 2000-02-04 |
| BILICHEK NON-INVASIVE BILIRUBIN ANALYZER (K983071) | Respironics, Inc. | 1999-03-04 |
| NBIL (K983134) | Abbott Laboratories | 1998-09-23 |
Recalls involving this device
No recalls on record reference this clearance.
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