CRP Lipid Reagent Test Pack
FDA 510(k) K905648 · Cirrus Diagnostics, Inc.
510(k) numberK905648
Submission
- Device name
- CRP Lipid Reagent Test Pack
- Applicant
- Cirrus Diagnostics, Inc.
Chester, NJ, US - Received
- December 17, 1990
- Decision date
- March 6, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CHH – Enzymatic Esterase--Oxidase, Cholesterol
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1175
- Specialty
- Clinical Chemistry
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| K203597 | Cholesterol2CHH · Traditional | Abbott Ireland Diagnostics Division | 06/30/2022SE |
| K190490 | VITROS XT Chemistry Products TRIG-CHOL SlidesCHH · Traditional | Ortho-Clinical Diagnostics, Inc. | 03/27/2019SE |
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| K163406 | Mission Cholesterol Monitoring System, Mission Cholesterol Pro Monitoring SystemCHH · Traditional | ACON Laboratories, Inc. | 07/11/2017SE |
| K151545 | CardioChek Plus Test System, CardioChek Home Test System, CardioChek PA Test System…CHH · Traditional | Polymer Technology Systems, Inc. | 12/22/2016SE |
| K150654 | CholesterolCHH · Traditional | Randox Laboratories, Ltd. | 09/29/2015SE |
| K132031 | Afinion Lipid Panel and Afinion Lipid Panel ControlCHH · Traditional | Axis-Shield Poc AS | 03/21/2014SE |
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| K921704 | Immulite(R) FSHCGJ · Traditional | 06/09/1992SE |
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| K914833 | Immulite DigoxinDPO · Traditional | 11/22/1991SE |
| K911796 | Immulite(Tm) HCGDHA · Traditional | 06/20/1991SE |
| K910677 | Immulite(Tm) T-UptakeCEE · Traditional | 04/29/1991SE |
| K910261 | Immulite(Tm) Total T4KLI · Traditional | 04/16/1991SE |
| K905214 | Immulite (TM) Total T3CDP · Traditional | 02/01/1991SE |
| K905769 | Immulite Hs-TshJLW · Traditional | 01/31/1991SE |
| K905215 | Immulite (TM) Automated Immunoassay AnalyzerJJQ · Traditional | 01/11/1991SE |
Questions and answers
When was CRP Lipid Reagent Test Pack cleared by the FDA?
CRP Lipid Reagent Test Pack (K905648) received a 510(k) decision of Substantially Equivalent on March 6, 1991, 79 days after the submission was received.
What is the product code of K905648?
The FDA product code is CHH – Enzymatic Esterase--Oxidase, Cholesterol, a Class I (low risk) device regulated under 21 CFR 862.1175.