Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator
FDA 510(k) K981978 · Pointe Scientific, Inc.,
510(k) numberK981978
Submission
- Device name
- Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator
- Applicant
- Pointe Scientific, Inc.,
Lincoln Park, MI, US - Received
- June 5, 1998
- Decision date
- July 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MRR – System, Test, Low Density, Lipoprotein
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
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More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K070757 | Microprotein Reagent SetJGP · Traditional | 12/04/2007SE |
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| K070251 | Carbon Dioxide Liquid Stable ReagentKHS · Traditional | 04/30/2007SE |
| K070207 | Multi-Analyte Chemistry CalibratorJIX · Abbreviated | 04/13/2007SE |
| K070504 | Ammonia/Alcohol Control SetJJY · Abbreviated | 04/11/2007SE |
| K061377 | Apolipoprotein A1 and Apolipoprotein B Reagents and CalibratorsMSJ · Traditional | 03/28/2007SE |
| K051646 | Ise Diluent, 1N KCL, Internal Reference and Ise Standards Low and HighJGS · Traditional | 10/07/2005SE |
| K040391 | Total Bilirubin Reagent SetCIG · Traditional | 06/02/2004SE |
| K031539 | Hemoglobin A1C Reagent SetLCP · Traditional | 08/06/2003SE |
| K023860 | Microalbumin Reagent Set and CalibratorsDDZ · Traditional | 04/28/2003SE |
Questions and answers
When was Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator cleared by the FDA?
Autoldl Cholesterol Reagent Set and Autoldl Cholesterol Calibrator (K981978) received a 510(k) decision of Substantially Equivalent on July 22, 1998, 47 days after the submission was received.
What is the product code of K981978?
The FDA product code is MRR – System, Test, Low Density, Lipoprotein, a Class I (low risk) device regulated under 21 CFR 862.1475.