Rep Hemoglobin Ief Kits (Cat. No. 3250)
FDA 510(k) K901143 · Helena Laboratories
510(k) numberK901143
Submission
- Device name
- Rep Hemoglobin Ief Kits (Cat. No. 3250)
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 12, 1990
- Decision date
- May 23, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JBD – System, Analysis, Electrophoretic Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7440
- Specialty
- Hematology
Other 510(k)s with product code JBD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053571 | Microgel Alkaline Hemoglobin Electrophoresis Test System, Microgel Acid Hemoglobin…JBD · Traditional | Interlab S.R.L. | 06/30/2006SE |
| K032862 | Interlab Alkaline Hemoglobin Electrophoresis Test SystemJBD · Traditional | Interlab S.R.L. | 02/03/2004SE |
| K992199 | Acid Hemoglobin KitJBD · Traditional | Helena Laboratories | 09/21/1999SE |
| K991362 | Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E)…JBD · Traditional | Morax | 06/21/1999SE |
| K982426 | Spife Alkaline HemoglobinJBD · Traditional | Helena Laboratories | 12/17/1998SE |
| K931503 | Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional | Helena Laboratories | 08/16/1993SE |
| K931465 | Rep Alkaline HB-15 #3196,-8 #3197,-4 3198JBD · Traditional | Helena Laboratories | 07/06/1993SE |
| K830804 | Labile Removing Hemolyzing ReagentJBD · Traditional | Corning Medical & Scientific | 05/04/1983SE |
| K820518 | Gelman Glyco-Phore BufferJBD · Traditional | Gelman Sciences, Inc. | 04/09/1982SE |
| K813395 | Cellulose Acetate-Citrate Agar HemogloJBD · Traditional | Helena Laboratories | 12/31/1981SE |
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|---|---|---|
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| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
| 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 |
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Questions and answers
When was Rep Hemoglobin Ief Kits (Cat. No. 3250) cleared by the FDA?
Rep Hemoglobin Ief Kits (Cat. No. 3250) (K901143) received a 510(k) decision of Substantially Equivalent on May 23, 1990, 72 days after the submission was received.
What is the product code of K901143?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.