Quantex Aso-Crp-Rf Control
FDA 510(k) K971777 · Instrumentation Laboratory CO
510(k) numberK971777
Submission
- Device name
- Quantex Aso-Crp-Rf Control
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- May 14, 1997
- Decision date
- May 27, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|
| K233790 | Acl Top 970 CLJPA · Special | 12/29/2023SE |
| K230852 | HemosIL Chromogenic Factor IXGGP · Traditional | 12/13/2023SE |
| K221359 | ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-ß2 Glycoprotein-I IgMJPA · Traditional | 09/29/2023SE |
| K223608 | GEM Premier 7000 with IQM3CHL · Traditional | 08/10/2023SE |
| K223187 | HemosIL Liquid Anti-XaQLU · Traditional | 06/23/2023SE |
| K231031 | ACL TOP Family 70 SeriesGKP · Traditional | 06/21/2023SE |
| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Quantex Aso-Crp-Rf Control cleared by the FDA?
Quantex Aso-Crp-Rf Control (K971777) received a 510(k) decision of Substantially Equivalent on May 27, 1997, 13 days after the submission was received.
What is the product code of K971777?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.