FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
Liquichek Maternal Serum II Control
K Number: K143379
·
Decision Mar 13, 2015
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
672
Applicant Total
46
Review Days
108
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Liquichek Maternal Serum II Control
- K Number
- K143379
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Rad Laboratories
- Date Received
- November 25, 2014
- Decision Date
- March 13, 2015
- Product Code
- JJY
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJY), ordered by most recent decision date.
Multichem IA Plus
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Audit MicroControls Linearity FD Tumor Markers II
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Liquichek Cardiac Markers Plus Control LT
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VALIDATE Anemia Calibration Verification/ Linearity Test Kit
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Bio-Rad Laboratories
| K Number | Device Name | ||
|---|---|---|---|
| K183446 | BioPlex 2200 Lyme Total | Mar 12, 2019 | Substantially Equivalent |
| K180577 | BioPlex 2200 25-OH Vitamin D Kit | Jun 22, 2018 | Substantially Equivalent |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM Control Set | May 19, 2017 | Substantially Equivalent |
| 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 |
| 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 |