510(k) K031380
- Device
- OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032)
- Applicant
- OLYMPUS AMERICA, INC.
- 510(k) number
- K031380
- Product code
- LCP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-11-14
- Date received
- 2003-05-01
- Regulation
- 864.7470
- Classification name
- Assay, Glycosylated Hemoglobin
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- MICHAEL CAMPBELL
- Address
- 3131 W. Royal Ln. Irving TX US 75063 75063
FDA Registration Numbers#
- 3043654757
- 3003422726
- 8020316
- 2030861
- 8023060
- 2517506
- 3016438761
- 3005333358
- 3003539867
- 3006198300
- 3009448641
- 3013660430
- 9680746
- 9610633
- 3004493545
- 2085064
- 1616487
- 3011061417
- 3002809144
- 1000487132
- 2027969
- 9611444
- 3008178161
- 3010825766
- 3023162659
- 1220972
- 9610126
- 3003460426
- 3023949424
- 1219029
- 3003795116
- 8043889
- 1181121
- 2084025
- 1832816
- 2032900
- 8031673
- 3002637618
- 1832216
- 1423455
- 3015525148
- 3004111573
- 3043149833
- 3006421415
- 1827821
- 8023024
- 2247288
- 1717966
- 2050012
- 9613069
- 3004529019
- 3035708936
- 2915274
- 9610529
- 3004145393
- 3003917514
- 3005529799
- 9612316
- 3012526002
- 1931251
- 3032069621
- 2050010
- 3007662974
- 3017548799
- 3014607865
- 2432235
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K221326 | Nova Allegro HbA1c Assay, Nova Allegro Analyzer | Nova Biomedical Corporation | 2024-11-22 |
| K231465 | Q-Pad Test System | Qurasense | 2023-12-06 |
| K214117 | Afinion™ HbA1c, Afinion™ 2 and Alere Afinion™ AS100 Analyzer | Abbott Diagnostics Technologies AS | 2023-09-27 |
| K192987 | Aina HbA1c Monitoring System 2 | Jana Care, Inc. | 2020-03-26 |
| K192369 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | 2019-10-29 |
| K183230 | OneDraw A1C Test System | Drawbridge Health, Inc. | 2019-08-15 |
| K181915 | PixoTest POCT System - PixoTest POCT Analyzer and PixoTest A1c Test Kit | Ixensor Co, Ltd. | 2019-04-12 |
| K180509 | Quo-Test A1c System | Ekf-Diagnostic GmbH | 2019-02-16 |
| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent Kit) | Skyla Corporation H.S.P.B | 2018-09-25 |
| K170623 | ACE Hemoglobin A1c (HbA1c) Reagent | Alfa Wassermann Diagnostic Technologies, LLC | 2018-02-27 |
| K171650 | Alere Afinion HbA1c and ACR on Afinion 2 analyzer | Abbott Rapid Diagnostics | 2017-11-21 |
| K170147 | Lucica Glycated Albumin-L | Asahi Kasei Pharma Corporation | 2017-10-12 |
| K163633 | cobas HbA1c Test, cobas b 101 system | Roche Diagnostics Operations | 2017-07-28 |
| K161533 | A1C EZ Glycohemoglobin Analysis System | Biohermes Co., Ltd. | 2017-06-16 |
| K162281 | CAPI 3 Hb A1c, MULTI-SYSTEM Hb A1C CAPILLARY CONTROLS (2) | Sebia | 2017-02-17 |
Legacy Summary#
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FDA Review#
Decision Summary