FDA 510(k) Applications for Medical Device:
Drug Specific Control Materials
| FDA 510(k) Number | Applicant | Address | City / Country | State / Province | Postal Code |
|---|---|---|---|---|---|
| K971210 | BECKMAN INSTRUMENTS, INC. |
200 SOUTH KRAEMER BLVD., W-337 | BREA | CA | 92622-8000 |
| K080459 | CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
1733 CANTON LANE | MARIETTA | GA | 30062-2679 |
| K992151 | CONSOLIDATED TECHNOLOGIES, INC. |
2170 WOODWARD STREET, STE. 100 | AUSTIN | TX | 78744-1832 |
| K030616 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K040411 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K051074 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K032842 | MICROGENICS CORP. |
46360 FREMONT BLVD. | FREMONT | CA | 94538 |
| K072257 | MORE DIAGNOSTICS |
2020 11TH ST. | LOS OSOS | CA | 93402 |
| K970517 | OXIS INTL., INC. |
6040 N. CUTTER CIRCLE, | PORTLAND | OR | 97217-3935 |
| K062942 | QUANTIMETRIX CORP. |
2005 MANHATTAN BEACH BLVD. | REDONDO BEACH | CA | 90278-1205 |
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