Opti-Check Plus Multi-Analyte Control, Model HC7009
FDA 510(k) K001632 · Avl Scientific Corp.
510(k) numberK001632
Submission
- Device name
- Opti-Check Plus Multi-Analyte Control, Model HC7009
- Applicant
- Avl Scientific Corp.
Roswell, GA, US - Received
- May 26, 2000
- Decision date
- June 19, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 |
|---|---|---|
| K000103 | Avl Opti R AnalyzerCHL · Traditional | 03/20/2000SE |
| K993837 | Avl Opti Critical Care AnalyzerCGA · Traditional | 12/16/1999SE |
| K990092 | Avl Omni Modular AnalyzerCHL · Traditional | 01/29/1999SE |
| K984299 | Avl Opti Critical Care AnalyzerJFP · Traditional | 12/11/1998SE |
| K974784 | Avl Opti Critical Care AnalyzerCEM · Traditional | 02/24/1998SE |
| K974822 | Avl Opti-Check Ph/ Blood Gas/ Electrolyte/Thb/ SO2 ControlJJY · Traditional | 01/22/1998SE |
| K972733 | Avl Omni AnalyzerCGA · Traditional | 09/09/1997SE |
| K972673 | Avl 9181 Electrolyte AnalyzerJFP · Traditional | 08/20/1997SE |
| K963964 | Avl Compact 3 Ph/Blood Gas AnalyzerCHL · Traditional | 11/29/1996SE |
| K961458 | Avl 9180 Electrolyte AnalyzerJFP · Traditional | 06/12/1996SE |
Questions and answers
When was Opti-Check Plus Multi-Analyte Control, Model HC7009 cleared by the FDA?
Opti-Check Plus Multi-Analyte Control, Model HC7009 (K001632) received a 510(k) decision of Substantially Equivalent on June 19, 2000, 24 days after the submission was received.
What is the product code of K001632?
The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.