Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2
FDA 510(k) K946049 · Clinical Controls, Inc.
510(k) numberK946049
Submission
- Device name
- Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2
- Applicant
- Clinical Controls, Inc.
Grover Beach, CA, US - Received
- December 12, 1994
- Decision date
- February 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JJY – Multi-Analyte Controls, All Kinds (Assayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K162530 | Multichem IA PlusJJY · Abbreviated | Techno-Path Manufacturing | 03/31/2017SE |
| K163629 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 03/10/2017SE |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2…JJY · Traditional | Bio-Rad Laboratories | 01/10/2017SE |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification…JJY · Traditional | Radiometer America, Inc. | 01/28/2016SE |
| K150300 | Liquichek Cardiac Markers Plus Control LTJJY · Traditional | Bio-Rad Laboratories | 12/11/2015SE |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test KitJJY · Traditional | Maine Standards Company, LLC | 04/30/2015SE |
| K143379 | Liquichek Maternal Serum II ControlJJY · Traditional | Bio-Rad Laboratories | 03/13/2015SE |
| K143573 | Audit MicroControls Linearity FD Tumor Markers IIJJY · Traditional | Aalto Scientific, Ltd. | 01/16/2015SE |
| K140971 | Liquid Assayed Chemistry Control Premium Plus Level 1,2 and Level 3.JJY · Traditional | Randox Laboratories Limited | 12/08/2014SE |
| K142978 | Audit MicroControls Linearity LQ Special DiabetesJJY · Traditional | Aalto Scientific, Ltd. | 11/20/2014SE |
More from Aalto Scientific, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K012907 | Liquispx Liquid Saliva or Unrine Drug of Abuse ControlDIF · Traditional | 09/28/2001SE |
| K964278 | Whole Blood Glucose Control Level 1,2,AND 3/WHOLE Blood Glucose Linearity…JJX · Traditional | 11/22/1996SE |
| K962432 | Liquispex Urine (Micro)Albumin ControlJJX · Traditional | 07/05/1996SE |
| K955691 | Serum Volatiles Control Level 1 & 2JJY · Traditional | 04/24/1996SE |
| K955690 | Aqueous Ethanol/Ammonia Control Level 1, 2, & 3JJY · Traditional | 04/24/1996SE |
| K946265 | Fibrinogen High Abnormal Control - Level 3GIL · Traditional | 08/24/1995SE |
| K935598 | Plasma Fibrinogen Control Level 1/LEVEL 2GIL · Traditional | 05/02/1995SE |
| K946266 | Ferritin Control - Level 1, 2, 3DGD · Traditional | 02/10/1995SE |
| K946050 | Liquispex(Tm) Liquid CRP Control Level 1 and 2DCK · Traditional | 02/10/1995SE |
| K946048 | Liquispex(Tm) Liquid B2M Control Level 1 and 2JZG · Traditional | 02/10/1995SE |
Questions and answers
When was Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2 cleared by the FDA?
Liquispex(Tm) Liquid B2M/CRP Control Level 1 and 2 (K946049) received a 510(k) decision of Substantially Equivalent on February 10, 1995, 60 days after the submission was received.
What is the product code of K946049?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.