Aia-Pack Brca, ST Aia Pack Brca
FDA 510(k) K010796 · Tosoh Medics, Inc.
510(k) numberK010796
Submission
- Device name
- Aia-Pack Brca, ST Aia Pack Brca
- Applicant
- Tosoh Medics, Inc.
South San Francisco, CA, US - Received
- March 16, 2001
- Decision date
- August 16, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- MOI – System, Test, Immunological, Antigen, Tumor
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
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|---|---|---|---|
| K240403 | Access BR MonitorMOI · Traditional | Beckman Coulter, Inc. | 05/09/2024SE |
| K233946 | Immulite® 2000 Br-MaMOI · Traditional | Siemens Healthcare Diagnostics Products, Ltd. | 03/13/2024SE |
| K192524 | Lumipulse G CA15-3MOI · Traditional | Fujirebio Diagnostics,Inc. | 09/04/2020SE |
| K193489 | ADVIA Centaur BRMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 02/13/2020SE |
| K192777 | ADVIA Centaur CA 15-3 assayMOI · Traditional | Siemens Healthcare Diagnostics, Inc. | 11/22/2019SE |
| K181492 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 06/22/2018SE |
| K171605 | Elecsys CA 15-3 IIMOI · Traditional | Roche Diagnostics | 02/20/2018SE |
| K100344 | Dimension Vista Loci Ca 15-3 Flex Reagent Cartridge, Dimension Vista Loci 7 Calibrator…MOI · Traditional | Siemens Healthcare Diagnostics | 04/18/2011SE |
| K072612 | Access Immunoassay Systems BR Monitor, and Calibrators, Model(S) 387620,AND 387647MOI · Special | Beckman Coulter, Inc. | 10/26/2007SE |
| K042732 | Architect Ca 15-3 AssayMOI · Traditional | Fujirebio Diagnostics,Inc. | 12/22/2004SE |
More from Fujirebio Diagnostics,Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K023893 | ST Aia-Pack Cea Enzyme ImmunoassayDHX · Special | 12/18/2002SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | 12/17/2002SE |
| K023091 | ST Aia-Pack Testosterone AssayCDZ · Traditional | 12/17/2002SE |
| K023891 | ST Aia-Pack Ca 125 Enzyme ImmunoassayLTK · Special | 12/06/2002SE |
| K020489 | G7 Automated HPLC Analyzer, Beta-Thalassemia ModeJPD · Traditional | 05/14/2002SE |
| K012820 | Aia-Pack Ctni 2ND-GEN AssayMMI · Traditional | 12/14/2001SE |
| K011434 | G7 Automated HPLC AnalyzerLCP · Traditional | 09/18/2001SE |
| K992365 | Aia-Pack Folate AssayCGN · Traditional | 08/10/1999SE |
| K990431 | Aia-Pack Ca 125LTK · Traditional | 06/03/1999SE |
| K991252 | Aia-Pack FT3 AssayCDP · Traditional | 05/11/1999SE |
Questions and answers
When was Aia-Pack Brca, ST Aia Pack Brca cleared by the FDA?
Aia-Pack Brca, ST Aia Pack Brca (K010796) received a 510(k) decision of Substantially Equivalent on August 16, 2001, 153 days after the submission was received.
What is the product code of K010796?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.