HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
FDA 510(k) clearance K021622 · decided 2003-04-01
Clearance details
- K-number
- K021622
- Device name
- HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103
- Applicant
- Hill-Rom Air-Shields
- Decision
- Substantially Equivalent
- Date received
- 2002-05-16
- Decision date
- 2003-04-01
- Days to decision
- 320 days
- Clearance type
- Traditional
- Product code
- MQM
- Device class
- 1
- Regulation number
- 862.1113
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hatboro, PA, 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 |
|---|---|---|
| ABL90 FLEX, ABL90 FLEX PLUS (K170882) | Radiometer Medical Aps | 2017-04-28 |
| DRAEGER JAUNDICE METER JM-105 (K133175) | Draeger Medical Systems, Inc. | 2014-11-13 |
| ABL90 FLEX (K132691) | Radiometer Medical Aps | 2014-11-13 |
| RAPIDPOINT 405 NEONATAL BILIRUBIN (K110277) | Siemens Healthcare Diagnostics | 2011-08-15 |
| NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265 (K073537) | Siemens Medical Solutions Diagnostics | 2008-06-27 |
| JAUNDICE METER, MODEL JM 103 (K042522) | Draeger Medical Infant Care, Inc. | 2005-07-06 |
| BILIRUBIN ASSAY ON THE OMNI S ANALYZER (K040174) | Roche Diagnostics Corp. | 2004-05-14 |
| 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.