510(k) K021697
- Device
- GLUCOSE CONTROL SOLUTION FOR BD LATITUDE
- Applicant
- BIONOSTICS, INC.
- 510(k) number
- K021697
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2002-07-12
- Date received
- 2002-05-22
- 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
- KATHLEEN STORRO
- Address
- 7 Jackson Rd. Devens MA US 01432 01432
FDA Registration Numbers#
- 1218959
- 3006948883
- 2050012
- 8020888
- 1645225
- 3009171251
- 3006644620
- 2521625
- 1832216
- 3012133212
- 3023591031
- 2432235
- 3007382160
- 3008606429
- 3003419906
- 3011989923
- 9610806
- 3009746061
- 1810909
- 9710595
- 3003593973
- 3003610890
- 9610746
- 3003951180
- 3011420269
- 3012963943
- 3000308930
- 9614373
- 9615507
- 8032314
- 2155
- 1643621
- 9681753
- 3003460426
- 3004009431
- 9710337
- 2954323
- 3006755541
- 2032087
- 2915274
- 2024800
- 3009469260
- 3013660430
- 3008959428
- 3008700497
- 3017500903
- 3002637618
- 3031259044
- 1000403749
- 3013223546
- 8043889
- 3010939897
- 8043909
- 3032705
- 1220649
- 1122376
- 2246703
- 3042026207
- 2245578
- 3027062375
- 9616673
- 3007118747
- 9610240
- 3016438761
- 3001058982
- 3008156187
- 3003561301
- 3003422726
- 2020715
- 3002694097
- 3015188281
- 3038419886
- 3003985394
- 3014353045
- 3004152597
- 3009901017
- 3003871639
- 3010713600
- 3005798905
- 3005333358
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 |
| 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#
summary
FDA Review#
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