ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
FDA 510(k) clearance K972986 · decided 1997-10-08
Clearance details
- K-number
- K972986
- Device name
- ACCURUN 140 RUBELLA IGG POSITIVE CONTROL
- Applicant
- Boston Biomedica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-08-11
- Decision date
- 1997-10-08
- Days to decision
- 58 days
- Clearance type
- Traditional
- Product code
- MJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Bridgewater, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SYSCOS IDC - G, IDC, BSC, IDC - G (K974262) | Scantibodies Laboratory, Inc. | 1997-12-24 |
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| OPUS(R) SEROLOGY CONTROLS, MODIFICATION (K934137) | Pb Diagnostic Systems, Inc. | 1994-03-07 |
| OPUS SEROLOGY CONTROLS (K925703) | Pb Diagnostics, Inc. | 1993-04-08 |
Recalls involving this device
No recalls on record reference this clearance.