510(k) K151742
- Device
- Contour Next Control Solution
- Applicant
- BAYER HEALTHCARE
- 510(k) number
- K151742
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-09-23
- Date received
- 2015-06-29
- Regulation
- 862.1660
- Classification name
- Single (specified) Analyte Controls (assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JENNIFER L. GREGORY
- Address
- 430 S. Beiger St. Mishawaka IN US 46544 46544
FDA Registration Numbers#
- 3009469260
- 8020316
- 3010131137
- 3014279513
- 3015188281
- 8043909
- 3008959428
- 3003559191
- 3007499349
- 3009092698
- 3012471076
- 3005644014
- 8023018
- 8021924
- 3005643513
- 1832216
- 1219029
- 2250051
- 8020888
- 3004146366
- 3003422726
- 3002809144
- 3011393376
- 1720929
- 3005847079
- 3001452053
- 3010127294
- 9610099
- 3011121740
- 3007710663
- 2245285
- 1000403749
- 3011420269
- 8043889
- 3015997711
- 3033507883
- 3003985394
- 9610746
- 3008606429
- 1649661
- 3007118747
- 3003593973
- 3008514395
- 1226774
- 1643621
- 3008700497
- 3013223546
- 9615507
- 3010830834
- 3006532271
- 2016706
- 2245451
- 3015347724
- 3031259044
- 1220649
- 3024512705
- 2030633
- 3005862821
- 3013472743
- 3033967997
- 9612316
- 3038419886
- 3016698405
- 3005395953
- 9615777
- 3000308930
- 3017772438
- 3002637618
- 1119779
- 3007382160
- 3003522182
- 3009491259
- 3004193489
- 1319809
- 2432235
- 3011213605
- 2032682
- 9611444
- 3013160357
Source Documents#
Other 510(k) Records For Product Code JJX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K170678 | Beta-CrossLaps CalCheck 5 | Roche Diagnostics | 2017-04-04 |
| K162173 | Elecsys CYFRA 21-1 CalCheck 5 | Roche Diagnostics | 2017-01-12 |
| K162514 | Multichem A1c | Technopath Manufacturing | 2016-10-26 |
| K161874 | Audit MicroControls Linearity DROP LQ Blood Glucose | Aalto Scientific, Ltd. | 2016-08-10 |
| K161526 | LIAISON CMV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161082 | IDS-iSYS 17-OH Progesterone Control Set, IDS-iSYS 17-OH Progesterone Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2016-05-17 |
| K152117 | Dropper hsCRP High Sensitivity CRP Control | Quantimetrix Corporation | 2016-04-21 |
| K143687 | ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-07-17 |
| K150955 | Elecsys Progesterone III Cal Check 5 | Roche Diagnostics | 2015-05-01 |
| K150132 | IMMULITE IGF Control Module, IMMULITE Gastrin Control Module | Siemens Healthcare Diagnostics | 2015-04-13 |
| K143324 | IDS-iSYS CTX-I Calibration Verifiers | Immunodiagnostic Systems , Ltd. | 2015-03-30 |
| K143373 | IMMULITE® 2000 Calcitonin Calibration Verification Material , IMMULITE® 2000 Prostatic Acid Phosphatase (PAP) Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-26 |
| K143636 | IMMULITE 2000 Androstenedione Calibration Verification Material, IMMULITE 2000 Troponin I Calibration Verification Material | Siemens Healthcare Diagnostics, Inc. | 2015-02-25 |
| K143680 | ADVIA Centaur IgE Master Curve Material | Siemens Healthcare Diagnostics, Inc. | 2015-01-27 |
Legacy Summary#
summary
FDA Review#
Decision Summary