510(k) K082714
- Device
- AUDIT MICROCV THERAPEUTIC DRUG (TDM) LINEARITY SET, MODEL K707M-5
- Applicant
- Aalto Scientific, Ltd.
- 510(k) number
- K082714
- Product code
- JJY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-19
- Date received
- 2008-09-17
- Regulation
- 862.1660
- Classification name
- Multi-Analyte Controls, All Kinds (Assayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Related Records
Applicant Contact
- Contact
- BRANDON J PEREZ
- Address
- 1959 Kellogg Ave. Carlsbad CA US 92008 92008
FDA Registration Numbers
- 3013660430
- 3003795116
- 3003030793
- 3004973408
- 9680746
- 9610806
- 2432235
- 9610529
- 1832216
- 3014150341
- 3004205692
- 8040374
- 9612316
- 3009491259
- 3004130086
- 3007662974
- 2026994
- 1717966
- 3008198807
- 3001431095
- 9610746
- 3002807968
- 3011979858
- 3013513377
- 3012471076
- 2085064
- 3003871639
- 3006602209
- 2027969
- 1319681
- 1219029
- 3000308930
- 3004102403
- 3002806944
- 3000148879
- 3010127294
- 3011096386
- 9614373
- 2084025
- 3007088335
- 3005935106
- 3009984016
- 2431530
- 9681518
- 8043792
- 1220477
- 3005333358
- 1319809
- 9613959
- 1217183
- 3010421384
- 3010939897
- 3002809144
- 1058931
- 3022977716
- 1000403749
- 2020726
- 3004152597
- 8032314
- 2032087
- 2247288
- 9610566
- 3005643513
- 3004493545
- 3007490412
- 2182501
- 2022375
- 1000256526
- 1220649
- 9681753
- 3007111389
- 2435505
- 3008156187
- 3027273565
- 1218959
- 3005706626
- 3013982035
- 3032705
- 8020316
- 3039353646
Source Documents
Other 510(k) Records For Product Code JJY
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K162530 | Multichem IA Plus | Techno-Path Manufacturing | 2017-03-31 |
| K163629 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2017-03-10 |
| K163015 | Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPak | Bio-Rad Laboratories | 2017-01-10 |
| K153712 | VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit | Radiometer America, Inc. | 2016-01-28 |
| K150300 | Liquichek Cardiac Markers Plus Control LT | Bio-Rad Laboratories | 2015-12-11 |
| K142964 | VALIDATE Anemia Calibration Verification/ Linearity Test Kit | Maine Standards Company, LLC | 2015-04-30 |
| K143379 | Liquichek Maternal Serum II Control | Bio-Rad Laboratories | 2015-03-13 |
| K143573 | Audit MicroControls Linearity FD Tumor Markers II | Aalto Scientific, Ltd. | 2015-01-16 |
| K140971 | LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. | Randox Laboratories Limited | 2014-12-08 |
| K142978 | Audit MicroControls Linearity LQ Special Diabetes | Aalto Scientific, Ltd. | 2014-11-20 |
| K133676 | ABX PENTRA MICRO ALB CONTROL L/H | HORIBA ABX SAS | 2014-07-11 |
| K141073 | LIQUICHEK TUMOR MARKER CONTROL | Bio-Rad Laboratories | 2014-06-23 |
| K140522 | RANDOX IMMUNOASSAY PREMIUM PLUS CONTROL LEVELS 1,2 AND LEVEL 3 AND IMMUNOASSAY PREMIUM PLUS TRI-LEVEL CONTROL | Randox Laboratories Limited | 2014-05-22 |
| K140916 | LIQUICHEK CARDIAC TROPONINS CONTROL, LEVELS 1,2 AND 3, TRILEVEL/MINIPAK | Bio-Rad Laboratories | 2014-05-06 |
| K140764 | LIQUICHEK IMMUNOLOGYCONTROL-LEVEL 1,LEVEL 2, LEVEL 3, MINIPAK | Bio-Rad Laboratories | 2014-04-25 |