Multi-Enzyme Linearity Solution
FDA 510(k) K880266 · Verichem Laboratories, Inc.
510(k) numberK880266
Submission
- Device name
- Multi-Enzyme Linearity Solution
- Applicant
- Verichem Laboratories, Inc.
East Providence, RI, US - Received
- January 22, 1988
- Decision date
- February 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJT – Enzyme Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K090940 | Spotcheck Blood Spot Control, AssayedJJT · Traditional | Astoria-Pacific, Inc. | 12/14/2009SE |
| K062751 | Modification to Quantimetrix Cardiasure Cardiac MarkerJJT · Special | Quantimetrix Corp. | 10/03/2006SE |
| K030768 | Cliniqa Liquid QC Cardiac Marker Control Levels 1, 2 & 3, Tri-LevelJJT · Traditional | Cliniqa Corporation | 03/21/2003SE |
| K030102 | Advia Centaur and ACS:180 Liquid Cardiac Markers 1, 2, 3JJT · Abbreviated | Bayer Healthcare, LLC | 01/24/2003SE |
| K021498 | Liquichek Cardiac Markers Control LT Level 1, 2, 3, and TrilevelJJT · Traditional | Bio-Rad | 05/24/2002SE |
| K012656 | Liquichek Cardiac Markers Control LT Level 1,2,3, Models 646,647,648JJT · Traditional | Bio-Rad | 09/06/2001SE |
| K993723 | Cardiasure Cardiac Markers ControlJJT · Traditional | Quantimetrix Corp. | 11/23/1999SE |
| K993715 | Qualitrol Cardiac Marker Control, Levels, 1,2 and 3JJT · Traditional | Seracare Technology | 11/16/1999SE |
| K992430 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | Medical Analysis Systems, Inc. | 08/30/1999SE |
| K984437 | Quantex Aso-Crp-Rp Control IIJJT · Traditional | Instrumentation Laboratory CO | 02/02/1999SE |
More from Instrumentation Laboratory CO
| 510(k) | Device | Decision |
|---|---|---|
| K112834 | Multi-Chemistry Standard Kit, Uric Acid Standard Kit, Urine Chemistry Stardand Kit…JIX · Abbreviated | 03/28/2012SE |
| K974290 | Microprotein Standard KitJIX · Traditional | 12/19/1997SE |
| K973345 | Matrix Plus Multi-Calibrator KitJIX · Traditional | 10/29/1997SE |
| K972333 | Ammonia/Iron Standard KitJIX · Traditional | 07/23/1997SE |
| K924904 | Hdl-Cholesterol Standard, ModificationJIS · Traditional | 01/13/1993SE |
| K912513 | Electrolyte ControlJJR · Traditional | 07/19/1991SE |
| K901113 | Matrix Plus(Tm) Chemistry Reference StandardJIS · Traditional | 03/29/1990SE |
| K882059 | Bilirubin StandardJIT · Traditional | 10/25/1988SE |
| K881320 | Urine Toxicology StandardDKB · Traditional | 09/09/1988SE |
| K875285 | Multi-Chemistry Linearity StandardJIX · Traditional | 09/02/1988SE |
Questions and answers
When was Multi-Enzyme Linearity Solution cleared by the FDA?
Multi-Enzyme Linearity Solution (K880266) received a 510(k) decision of Substantially Equivalent on February 18, 1988, 27 days after the submission was received.
What is the product code of K880266?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.