Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak
FDA 510(k) K042336 · Bio-Rad Laboratories, Inc.
510(k) numberK042336
Submission
- Device name
- Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak
- Applicant
- Bio-Rad Laboratories, Inc.
Irvine, CA, US - Received
- August 30, 2004
- Decision date
- October 14, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
Other 510(k)s with product code JPK
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K160590 | XN CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160588 | XN Check BFJPK · Traditional | Streck | 12/22/2016SE |
| K160586 | Xn-L CheckJPK · Traditional | Streck | 12/22/2016SE |
| K160606 | BC-5D Hematology ControlJPK · Traditional | R&D Systems, Inc. | 09/01/2016SE |
| K141964 | XN CheckJPK · Traditional | Streck | 12/05/2014SE |
| K141957 | XN Check BFJPK · Traditional | Streck | 12/05/2014SE |
| K130962 | R&D 5D Retic Hematology ControlJPK · Special | R&D Systems, Inc. | 07/24/2013SE |
| K120744 | XN Check BFJPK · Traditional | Streck | 10/19/2012SE |
| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
More from R&D Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K183446 | BioPlex 2200 Lyme TotalLSR · Traditional | 03/12/2019SE |
| K181661 | QXDx BCR-ABL %IS Kit for use on the QXDx AutoDG ddPCR SystemOYX · Traditional | 02/13/2019SE |
| K180577 | BioPlex 2200 25-OH Vitamin D KitMRG · Traditional | 06/22/2018SE |
| K171664 | Hemoglobin Variants System on Newborn Hemoglobin System with GDM and HbReview SoftwareGKA · Special | 09/13/2017SE |
| K170509 | BioPlex 2200 ToRC IgM, BioPlex 2200 ToRC IgM Calibrator Set, BioPlex 2200 ToRC IgM…PUQ · Traditional | 05/19/2017SE |
| K170413 | BioPlex 2200 Syphilis Total & RPR, BioPlex 2200 Syphilis Total & RPR Calibrator Set…LIP · Traditional | 05/11/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | 01/10/2017SE |
| K161687 | D-10 Hemoglobin A1c ProgramPDJ · Traditional | 10/14/2016SE |
| K152679 | Amplichek I, Negative , Amplichek I, Level 1, Amplichek I, Level 2, Amplichek I, Level…PMN · Traditional | 05/10/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | 12/11/2015SE |
Questions and answers
When was Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak cleared by the FDA?
Meter Trax Trilevel, Low Level, Mid Level, High Level Trilevel Minipak (K042336) received a 510(k) decision of Substantially Equivalent on October 14, 2004, 45 days after the submission was received.
What is the product code of K042336?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.