Spotcheck Blood Spot Control, Assayed
FDA 510(k) K090940 · Astoria-Pacific, Inc.
510(k) numberK090940
Submission
- Device name
- Spotcheck Blood Spot Control, Assayed
- Applicant
- Astoria-Pacific, Inc.
Clackamas, OR, US - Received
- April 3, 2009
- Decision date
- December 14, 2009
- 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
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| 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 |
| K984277 | Cardioimmune Cardiac Marker Control Levels 1,2, and 3JJT · Traditional | Medical Analysis Systems, Inc. | 12/09/1998SE |
More from Medical Analysis Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K121101 | Spotcheck Neonatal Total Galactose Microplate Reagent KitJIA · Traditional | 06/20/2013SE |
| K102643 | Spotcheck Neonatal Galt Microplate Reagent KitKQP · Traditional | 07/15/2011SE |
| K101392 | Neopac Software, 3007 Digital Photometer/Fluorometer Model Na, 307 and 350DKQP · Traditional | 02/04/2011SE |
| K080294 | Astoria-Pacific Spotcheck Biotinidase Microplate Reagent KitNAK · Traditional | 11/04/2008SE |
| K010844 | Astoria-Pacific Spotcheck Biotinidase Kit, 50 Hour, Part No. 80-8000-13KNAK · Traditional | 09/21/2001SE |
| K990957 | Astoria-Pacific Spotcheck G6PD Kit 50 HR, Model 80-3000-13KJBL · Traditional | 05/11/1999SE |
| K970093 | Tyrosine 50-HOUR Reagent KitCDR · Traditional | 03/19/1998SE |
| K970277 | Uridyltransferase Kit, 50 Hour (80-4000-13K)KQP · Traditional | 12/11/1997SE |
Questions and answers
When was Spotcheck Blood Spot Control, Assayed cleared by the FDA?
Spotcheck Blood Spot Control, Assayed (K090940) received a 510(k) decision of Substantially Equivalent on December 14, 2009, 255 days after the submission was received.
What is the product code of K090940?
The FDA product code is JJT – Enzyme Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.