FDA 510(k) Applications for Medical Device:
Bilirubin (Total And Unbound) In The Neonate Test System
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K983134 | ABBOTT LABORATORIES |
1920 HURD DR. | IRVING | TX | 75038 |
| K972309 | AIR-SHIELDS, INC. |
12300 TWINBROOK PKWY. | ROCKVILLE | MD | 20852 |
| K964590 | CHROMATICS COLOR SCIENCES INTL., INC. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K001687 | CHROMATICS COLOR SCIENCES INTL., INC. |
16809 BRIARDALE RD. | ROCKVILLE | MD | 20855 |
| K042522 | DRAEGER MEDICAL INFANT CARE, INC. |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K133175 | DRAEGER MEDICAL SYSTEMS, INC. |
3135 QUARRY RD. | TELFORD | PA | 18969 |
| K021622 | HILL-ROM AIR-SHIELDS |
330 JACKSONVILLE RD. | HATBORO | PA | 19040 |
| K980646 | INSTRUMENTATION LABORATORY CO. |
113 HARTWELL AVE. | LEXINGTON | MA | 02173 |
| K132691 | RADIOMETER MEDICAL APS |
AKANDEVEJ 21 | BRONSHOJ | DK-2700 | |
| K170882 | Radiometer Medical ApS |
Aakandevej 21 | Broenshoej | DK-2700 | |
| K983071 | RESPIRONICS, INC. |
1501 ARDMORE BLVD. | PITTSBURGH | PA | 15221-4401 |
| K010052 | RESPIRONICS, INC. |
125 CHASTAIN MEADOW COURT | KENNESAW | GA | 30144-3724 |
| K040174 | ROCHE DIAGNOSTICS CORP. |
9115 HAGUE ROAD | INDIANAPOLIS | IN | 46256 |
| K110277 | SIEMENS HEALTHCARE DIAGNOSTICS |
2 EDGEWATER DRIVE | NORWOOD | MA | 02062 |
| K073537 | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
2 EDGEWATER DR. | NORWOOD | MA | 02062 |
| K994438 | SPECTRX, INC. |
49 PLAIN ST. | NORTH ATTLEBORO | MA | 02760 |
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