510(k) K893139
- Device
- DOCUMENT(TM) URIC ACID LINEARITY TEST SET
- Applicant
- CASCO STANDARDS
- 510(k) number
- K893139
- Product code
- JIT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-07-20
- Date received
- 1989-04-25
- Regulation
- 862.1150
- Classification name
- Calibrator, Secondary
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
Other 510(k) Records For Product Code JIT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K171168 | VITROS Immunodiagnostic Products Insulin Calibrators | Ortho Clinical Diagnostics | 2017-05-16 |
| K170938 | CalSet IGF-1 | Roche Diagnostics | 2017-04-26 |
| K170160 | Abbott ARCHITECT Free T3 | Abbott Laboratories | 2017-02-15 |
| K163534 | Lumipulse G FSH-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163546 | Lumipulse G Progesterone-N Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-13 |
| K163521 | Lumipulse G LH Calibrators | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163544 | Lumipulse G Prolactin | Fujirebio Diagnostics,Inc. | 2017-01-12 |
| K163078 | DC-UIBC-CAL | Sekisui Diagnostics P.E.I., Inc. | 2016-12-08 |
| K163053 | Lumipulse G E2-III Calibrators | Fujirebio Diagnostics,Inc. | 2016-12-01 |
| K162538 | ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator | Siemens Healthcare Diagnostics | 2016-11-17 |
| K160113 | ST AIA-PACK hsE2 Calibrator Set | Tosoh Bioscience, Inc. | 2016-02-17 |
| K153417 | ST AIA-PACK PROG III Calibrator Set | Tosoh Bioscience, Inc. | 2015-12-18 |
| K152526 | Elecsys Progesterone III CalSet | Roche Diagnostics | 2015-10-02 |
| K151566 | Abbott ARCHITECT Total T4 Calibrators | Abbott Laboratories | 2015-07-10 |
| K142985 | UniCel DxC SYNCHRON System HDL Cholesterol reagent(HDL),Unicel DxC SYNCHRON System HDL Calibrator | Beckman Coulter, Inc. | 2015-02-26 |
Legacy Summary#
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FDA Review#
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