Company ยท US
Aalto Scientific, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2017. Name variants (Inc, Corp, punctuation) are merged.
35510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 19 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 9 |
| GGN | Plasma, Coagulation Control | 1 |
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 1 |
| GLK | Control, Hematocrit | 1 |
| JJR | Electrolyte Controls (Assayed And Unassayed) | 1 |
| JJT | Enzyme Controls (Assayed And Unassayed) | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| MJX | Kit, Serological, Positive Control | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 10, 2017 | K163629 | Audit MicroControls Linearity FD Tumor Markers II Aalto Scientific, Ltd. | JJY |
| Aug 10, 2016 | K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose Aalto Scientific, Ltd. | JJX |
| Jan 23, 2015 | K143571 | Audit MicroControls Linearity LQ Cystatin-C Aalto Scientific, Ltd. | JJX |
| Jan 16, 2015 | K143573 | Audit MicroControls Linearity FD Tumor Markers II Aalto Scientific, Ltd. | JJY |
| Nov 21, 2014 | K143026 | Audit MicroControls Linearity FD Unsaturated Iron Binding Capacity Aalto Scientific, Ltd. | JJX |
| Nov 20, 2014 | K142978 | Audit MicroControls Linearity LQ Special Diabetes Aalto Scientific, Ltd. | JJY |
| Apr 29, 2013 | K130762 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Apr 26, 2013 | K130764 | AUDIT MICROCV VITAMIN D LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Mar 19, 2013 | K130157 | AUDIT MICROCV BETA-HYDROXYBUTYRIC ACID LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Jun 15, 2012 | K112742 | AUDIT MICROLQ SPINAL FLUID CONTROL Aalto Scientific, Ltd. | JJY |
| Mar 2, 2012 | K111964 | AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY Aalto Scientific, Ltd. | JJY |
| Jan 31, 2012 | K112143 | AUDIT MICROCV T-UPTAKE LINEARITY Aalto Scientific, Ltd. | JJX |
| Jan 24, 2012 | K112705 | AUDIT(R) MICROLQ(TM) SERUM PROTEIN CONTROL Aalto Scientific, Ltd. | JJY |
| Jun 23, 2011 | K100716 | AUDIT MICROCV D-DIMER LINEARITY SET, MODEL K717M-5 Aalto Scientific, Ltd. | GGN |
| Jun 10, 2011 | K103601 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Jan 14, 2011 | K101216 | AUDIT MICROCV PROTEIN LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Jan 10, 2011 | K102617 | AUDIT MICROCV CARDIAC MARKERS LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Dec 23, 2010 | K101427 | AUDIT MICROCV HS-CRP LINEARITY SET Aalto Scientific, Ltd. | JJX |
| Dec 23, 2010 | K100715 | AUDIT MICROCV HOMOCYSTEINE LINEARITY SET, MODEL 704M-5 Aalto Scientific, Ltd. | JJX |
| Sep 3, 2010 | K100718 | AUDIT MICROCV AMMONIAN/ETHANOL LINEARITY SET, MODEL K712M-5 Aalto Scientific, Ltd. | JJY |
| Aug 31, 2010 | K101226 | AUDIT MICROCV RF/CRP LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Jul 22, 2010 | K101434 | AUDIT MICROCV PROCALCITONIN LINEARITY Aalto Scientific, Ltd. | MJX |
| May 21, 2010 | K100750 | AUDIT MICROCV ASO LINEARITY SET, MODEL K721M-5 Aalto Scientific, Ltd. | JJX |
| Nov 19, 2008 | K082714 | AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5 Aalto Scientific, Ltd. | JJY |
| Oct 30, 2008 | K082717 | AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 Aalto Scientific, Ltd. | JJY |
| Mar 13, 2007 | K070223 | AUDIT MICROCV LIPIDS LINEARITY SET (LOW) Aalto Scientific, Ltd. | JJY |
| Oct 16, 2006 | K062668 | AUDIT MICROCV IMMUNOASSAY LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Dec 9, 2004 | K042318 | AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET Aalto Scientific, Ltd. | JJY |
| Sep 9, 2003 | K032122 | AUDIT MICROCONTROLS MICROFD BNP CONTROL Aalto Scientific, Ltd. | JJY |
| May 14, 2002 | K020618 | AALTO SCIENTIFIC MIRCO HEMATOCRIT CONTROL Aalto Scientific, Ltd. | GLK |
| Feb 29, 1996 | K952126 | AALTO SCIENTIFIC LIQUID CEREBROSPINAL FLUID CONTROLS LEVELS I AND II Aalto Scientific, Ltd. | GGP |
| Oct 7, 1995 | K954074 | AALTO SCIENTIFIC LIQUID CARDIAC CONTROL Aalto Scientific, Ltd. | JJY |
| Sep 20, 1995 | K952720 | AALTO SCIENTIFIC LTD. GLYCATED HEMOGLOBIN CONTROL LEVELS I & II Aalto Scientific, Ltd. | JPK |
| May 2, 1995 | K951435 | AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL Aalto Scientific, Ltd. | JJR |
| Mar 4, 1982 | K820360 | AALTO LDH ISOENZYME CONTROL SERUM Aalto Scientific, Ltd. | JJT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||