FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
K Number: K170509
·
Decision May 19, 2017
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
0
Applicant Total
46
Review Days
87
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Basic Information
- Device Name
- BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set
- K Number
- K170509
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3510
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories
- Date Received
- February 21, 2017
- Decision Date
- May 19, 2017
- Product Code
- PUQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| PUQ | Multiplex Flow Immunoassay, T. Gondii, Rubella, Cmv Igm | FDA class 2 | Microbiology |
Other Clearances by Bio-Rad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | Mar 12, 2019 | Substantially Equivalent |
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| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set, BioPlex 2200 Syphilis Total & RPR Control Set | May 11, 2017 | Substantially Equivalent |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Jan 10, 2017 | Substantially Equivalent |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level 3, Amplichek I, MiniPak | May 10, 2016 | Substantially Equivalent |
| DEN150058 | Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak | Mar 28, 2016 | Unknown |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Dec 11, 2015 | Substantially Equivalent |
| K143379 | Liquichek Maternal Serum II Control | Mar 13, 2015 | Substantially Equivalent |
| K141114 | BIOPLEX(R) 2200 25-OH VITAMIN D KIT, BIOPLEX(R) 2200 25-OH VITAMIN D CALIBRATOR SET, AND BIOPLEX(R) 2200 25-OH VITAMIN D | Jan 9, 2015 | Substantially Equivalent |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Jun 23, 2014 | Substantially Equivalent |