510(k) K981864
- Device
- ACCESS AFP QC ON THE ACCESS IMMUNOASSAY ANALYZER, MODEL NUMBER 33219
- Applicant
- BECKMAN COULTER, INC.
- 510(k) number
- K981864
- Product code
- JJX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-12
- Date received
- 1998-05-27
- 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
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ELLEN M VOSS
- Address
- 1000 Lake Hazeltine Dr. Chaska MN US 55318 55318
FDA Registration Numbers#
- 2432495
- 3013660430
- 9611444
- 1825740
- 1119779
- 3010864358
- 3004637226
- 1000113657
- 1063851
- 1645225
- 3003674698
- 3004973408
- 9610806
- 3012113276
- 3004529019
- 3008789114
- 9610529
- 2432235
- 9615837
- 1832216
- 3014150341
- 3009901017
- 3008344661
- 9612316
- 2133772
- 3007499349
- 3005644014
- 3009491259
- 3009518015
- 3004130086
- 3011121740
- 2521625
- 3009092698
- 3007662974
- 2026994
- 3003600763
- 2155
- 1717966
- 3030186688
- 3014353121
- 3005862821
- 9610746
- 9615507
- 3011979858
- 3015997711
- 1832816
- 3016438761
- 3030978471
- 3015972771
- 2954323
- 3033751096
- 3012471076
- 3003422726
- 3003871639
- 3002807722
- 9610240
- 2085064
- 8020888
- 3004167884
- 1319681
- 3009171251
- 1219029
- 3012422258
- 3000308930
- 3007137761
- 3002806944
- 3000148879
- 3010127294
- 3006644620
- 2434178
- 9614373
- 3006948883
- 2084025
- 3010152370
- 3007088335
- 3005393828
- 3003749380
- 3005094123
- 3016863723
- 3007652384
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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