510(k) K981281
- Device
- ELECSYS CALCHECK FERRITIN
- Applicant
- ROCHE DIAGNOSTICS GMBH
- 510(k) number
- K981281
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-24
- Date received
- 1998-04-08
- 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
- PATRICIA M KLIMELY
- Address
- 4300 Hacienda Dr. Pleasanton CA US 94566 94566
FDA Registration Numbers#
- 3003561301
- 1000113657
- 3001058982
- 3007088335
- 8023018
- 3003741796
- 2432495
- 3003593973
- 3001452053
- 3003539867
- 9610566
- 9610529
- 2032900
- 3007363438
- 3000148879
- 1825740
- 1616487
- 3005644014
- 3005621222
- 3004145393
- 3008156187
- 3017550662
- 3042026207
- 1218959
- 3007382160
- 3009901017
- 1000403749
- 3002642396
- 3003460426
- 2250051
- 3038419886
- 3008700497
- 2030633
- 3030978471
- 3027062375
- 8031673
- 3014607865
- 3012133212
- 1122236
- 3005847079
- 3016438761
- 3015972771
- 8020316
- 2245285
- 2432235
- 2024800
- 3004167884
- 3017772438
- 2020715
- 3011121740
- 3003917514
- 1219029
- 1063851
- 3004637226
- 8043909
- 9610240
- 3003610890
- 3008959428
- 3009189893
- 3005529799
- 1217183
- 9613069
- 9710595
- 3005862821
- 3002792284
- 2032098
- 2245451
- 3002809144
- 2954323
- 3007137761
- 2024674
- 2016706
- 1645225
- 3010534606
- 3021611414
- 2032682
- 3000308930
- 3012471076
- 3006532271
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 |
| K151742 | Contour Next Control Solution | Bayer Healthcare | 2015-09-23 |
| 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 |
Legacy Summary#
summary
FDA Review#
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