Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2KBR
FDA 510(k) K013984 · Diagnostic Products Corp.
510(k) numberK013984
Submission
- Device name
- Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2KBR
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- December 3, 2001
- Decision date
- March 28, 2002
- 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
Other 510(k)s with product code MOI
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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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2KBR cleared by the FDA?
Immulite Br-Ma, Model #Lkbr; Immulite 2000 Br-Ma, Model #L2KBR (K013984) received a 510(k) decision of Substantially Equivalent on March 28, 2002, 115 days after the submission was received.
What is the product code of K013984?
The FDA product code is MOI – System, Test, Immunological, Antigen, Tumor, a Class II (moderate risk) device regulated under 21 CFR 866.6010.