510(k) K000231
- Device
- TRIAGE BNP CALIBRATION VERIFICATION CONTROLS
- Applicant
- BIOSITE INCORPORATED
- 510(k) number
- K000231
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-03-02
- Date received
- 2000-01-27
- 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
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOHN F BRUNI
- Address
- 11030 Roselle St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3006198300
- 9710337
- 3005643513
- 3004146366
- 3015997711
- 2050012
- 3010152370
- 3011325031
- 1226774
- 2531491
- 3007088335
- 9614373
- 3014607865
- 3002642396
- 3006532271
- 8043909
- 2250051
- 3030978471
- 3012113276
- 3003422726
- 3001452053
- 3017772438
- 3004529019
- 3004493545
- 3004193489
- 2245451
- 3007499349
- 3026478116
- 3007652384
- 2122870
- 2020715
- 1319809
- 3012348571
- 2123774
- 3005395953
- 3009469260
- 3014150341
- 3016438761
- 1217183
- 1220649
- 3006371704
- 9616530
- 3003982601
- 3008700497
- 3005798905
- 3012422258
- 3002809144
- 3018940143
- 2085064
- 1616487
- 1063851
- 3024512705
- 3007662974
- 3017520431
- 3017550662
- 3007886372
- 3005393828
- 2016706
- 3005862821
- 3004183148
- 1000134386
- 1000115322
- 2432235
- 3003749380
- 1649661
- 1000403749
- 3013223546
- 3014353045
- 3011979858
- 3011121740
- 3004130086
- 8043889
- 3010864358
- 3013472743
- 9611444
- 9610746
- 1319681
- 3045951983
- 2032087
- 2954323
Source Documents#
510(k) summary PDF not indicated by FDA
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 |
| K161522 | LIAISON EBV IgM Serum Control Set | DiaSorin, Inc. | 2016-06-30 |
| K161526 | LIAISON CMV 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#
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FDA Review#
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