Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2
FDA 510(k) K983263 · Diagnostic Products Corp.
510(k) numberK983263
Submission
- Device name
- Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- September 17, 1998
- Decision date
- December 7, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.6010
- Specialty
- Immunology
Other 510(k)s with product code LOJ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K220176 | Elecsys AFPLOJ · Traditional | Roche Diagnostics | 09/15/2022SE |
| K213626 | Vitros AfpLOJ · Traditional | Ortho Clinical Diagnostics | 06/15/2022SE |
| K090236 | Dimension Vista Afp Flex Reagent Cartridge, Model 6454LOJ · Traditional | Siemens Healthcare Diagnostics | 04/27/2009SE |
| K081709 | Olympus Afp - Alpha-FetoproteinLOJ · Traditional | Olympus Life Science Research Europa GmbH (Europa) | 03/16/2009SE |
| K080017 | Vidas Afp AssayLOJ · Traditional | bioMerieux, Inc. | 09/26/2008SE |
| K071597 | Dimension Vista (R) Afp Flex(R) Reagent Cartridge, Model K6454, Dimension Vista (R) Loci…LOJ · Traditional | Dade Behring, Inc. | 06/04/2008SE |
| K023894 | ST Aia-Pack Afp Enzyme ImmunoassayLOJ · Special | Tosoh Medics, Inc. | 12/17/2002SE |
| K020807 | Afp Assay for the Advia Integrated Modular SystemLOJ · Traditional | Bayer Diagnostics Corp. | 10/01/2002SE |
| K020806 | ACS:180 & Advia Centaur Afp ImmunoassayLOJ · Special | Bayer Corp. | 03/27/2002SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | Diagnostic Systems Laboratories, Inc. | 06/21/1999SE |
More from Diagnostic Systems Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
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| 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 Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2 cleared by the FDA?
Immulite Afp, Model Lkapi, LKAP5, Immulite 2000 Afp, Model L2KAP2 (K983263) received a 510(k) decision of Substantially Equivalent on December 7, 1998, 81 days after the submission was received.
What is the product code of K983263?
The FDA product code is LOJ – Kit, Test,Alpha-Fetoprotein For Testicular Cancer, a Class II (moderate risk) device regulated under 21 CFR 866.6010.