Spife Urine Ife
FDA 510(k) K982639 · Helena Laboratories
510(k) numberK982639
Submission
- Device name
- Spife Urine Ife
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- July 29, 1998
- Decision date
- November 4, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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|---|---|---|---|
| K040431 | Roche Diagnostics Tina-Quant Igm GEN.2DAO · Special | Roche Diagnostics Corp. | 03/10/2004SE |
| K955908 | Boehringer Mannheim Igm AssayDAO · Traditional | Boehringer Mannheim Corp. | 02/09/1996SE |
| K850586 | SPQ Test System for Immunoglobulin MDAO · Traditional | Applications Lab | 03/14/1985SE |
| K841992 | Modification to Acs Coronary GuidingDAO · Traditional | Advanced Cardiovascular Systems, Inc. | 06/11/1984SE |
| K812487 | Immunogl. Frct. of Rabbit Antiser.-IgmDAO · Traditional | Dako Corp. | 09/23/1981SE |
| K800450 | Gemeni Igm AssayDAO · Traditional | Electro-Nucleonics Laboratories, Inc. | 04/24/1980SE |
| K790705 | Antiserum to Human IgmDAO · Traditional | Kent Laboratories, Inc. | 04/12/1979SESP |
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| K061991 | Plateletworks Arachidonic Acid, Model Pw-AcaGHR · Traditional | 02/23/2007SE |
| K061069 | Spife IFE-15 Pentavalent, Model 3456, Spife IFE-9 Pentavalent Kit, Model 3457, Spift…CFF · Traditional | 07/06/2006SE |
| K061014 | Actalyke QC Kit, Models Aqc-Hp and Aqc-LpJPA · Special | 05/10/2006SE |
| K050053 | Hemoram/Aggram AnalyzerJPA · Traditional | 07/11/2005SE |
| K024162 | Spife 3000 Titan Gel Igg Ief Kit, Model 3389CFF · Traditional | 02/19/2003SE |
| K023761 | Plateletworks, Models Pw-A, Pw-CJOZ · Traditional | 02/14/2003SE |
Questions and answers
When was Spife Urine Ife cleared by the FDA?
Spife Urine Ife (K982639) received a 510(k) decision of Substantially Equivalent on November 4, 1998, 98 days after the submission was received.
What is the product code of K982639?
The FDA product code is DAO – Igm (Mu Chain Specific), Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.