Statspin Hdl-Cholesterol Precipitating Micro Tube
FDA 510(k) K890669 · Norfolk Scientific, Inc.
510(k) numberK890669
Submission
- Device name
- Statspin Hdl-Cholesterol Precipitating Micro Tube
- Applicant
- Norfolk Scientific, Inc.
Norwood, MA, US - Received
- February 9, 1989
- Decision date
- March 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBR – Ldl & Vldl Precipitation, Hdl
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1475
- Specialty
- Clinical Chemistry
Other 510(k)s with product code LBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K143691 | LDLC3 LDL-Cholesterol Gen.3LBR · Traditional | Roche Diagnostics Operations (Rdo) | 01/28/2015SE |
| K072523 | Diazyme Ldl-Cholesterol Reagent, Calibrator and ControlsLBR · Traditional | General Atomics | 01/22/2008SE |
| K050823 | Direct HDL Cholesterol and Direct Hdl/Ldl CalibratorLBR · Traditional | Teco Diagnostics | 07/26/2005SE |
| K023784 | Raichem HDL Cholesterol Using Cantrol HDL Precipitating Tubes on the Cobas Mira AnaylzerLBR · Special | Hemagen Diagnostics, Inc. | 12/24/2002SE |
| K012593 | Vitros Chemistry Products Magnetic Hdl-Cholesterol Reagent, Vitros Chemistry Products…LBR · Special | Ortho-Clinical Diagnostics, Inc. | 08/30/2001SE |
| K992029 | Atac Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Diagnostics | 08/12/1999SE |
| K992002 | Autohdl Cholesterol Reagent SetLBR · Traditional | Pointe Scientific, Inc., | 08/05/1999SE |
| K991789 | Atac-Pak Direct HDL Cholesterol Reagent and Atac Hdl-C Calibrator KitsLBR · Traditional | Elan Holdings, Inc. | 07/09/1999SE |
| K990247 | MTM Bioscanner HDL, Model # BSA450, BSA460, BSA470LBR · Traditional | Polymer Technology Systems, Inc. | 05/28/1999SE |
| K984303 | Vitros Chemistry Products Magnetic Hdl-Cholesterol ReagentLBR · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/28/1999SE |
More from Ortho-Clinical Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K902028 | Statspin Illuminated Micro-Hematocrit Tube ReaderJPI · Traditional | 06/20/1990SE |
| K883185 | Safecrit Plastic Microhematocrit TubesGHY · Traditional | 08/18/1988SE |
| K881254 | Statspin Disposable Rotor, Product #RD01JQC · Traditional | 04/05/1988SE |
| K870511 | Chart-Type Micro Hematocrit Tube ReaderJPI · Traditional | 03/16/1987SE |
| K864974 | General Purpose CentrifugeJQC · Traditional | 01/09/1987SE |
| K860172 | Qwikspin (TM)JQC · Traditional | 02/11/1986SE |
Questions and answers
When was Statspin Hdl-Cholesterol Precipitating Micro Tube cleared by the FDA?
Statspin Hdl-Cholesterol Precipitating Micro Tube (K890669) received a 510(k) decision of Substantially Equivalent on March 8, 1989, 27 days after the submission was received.
What is the product code of K890669?
The FDA product code is LBR – Ldl & Vldl Precipitation, Hdl, a Class I (low risk) device regulated under 21 CFR 862.1475.