ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)
FDA 510(k) K981698 · Chiron Corp.
510(k) numberK981698
Submission
- Device name
- ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29)
- Applicant
- Chiron Corp.
Emeryville, CA, US - Received
- May 14, 1998
- Decision date
- July 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|
| K980190 | Acs 180 BR (Automated Chemiluminescence System)MOI · Traditional | 03/06/1998SE |
Questions and answers
When was ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29) cleared by the FDA?
ACS:180 BR (Automated Chemiluminescence System for the Quantitation of Cancer Antigen 27.29) (K981698) received a 510(k) decision of Substantially Equivalent on July 10, 1998, 57 days after the submission was received.
What is the product code of K981698?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.