Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E) Hemoglobin(E), Mini Acid(E) Hemo)
FDA 510(k) K991362 · Morax
510(k) numberK991362
Submission
- Device name
- Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E) Hemoglobin(E), Mini Acid(E) Hemo)
- Applicant
- Morax
Chelsea, MI, US - Received
- April 14, 1999
- Decision date
- June 21, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K901143 | Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional | Helena Laboratories | 05/23/1990SE |
| 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 |
More from Helena Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K033277 | Hydragel CSF Isofocusing KitsCFF · Special | 11/04/2003SE |
| K012789 | Modified to Ldl/Hdl Chol Direct Kit-P.N. 4005, 4103,4123JHO · Special | 01/17/2002SE |
| K992148 | Hydragel-Mini Iso-Ck Kit, Hydragel Iso-Ck Kit, Hydragel 7 IS0-CK Kit, Hydragel Iso-Ck…CGS · Traditional | 12/29/1999SE |
| K990250 | Hydragel Ldl/Hdl Chol Direct Kit-P.N. 4005, Hydragel 7 Ldl/Hdl Chol Direct Kit-P.N.…LBT · Traditional | 06/18/1999SE |
| K981048 | Hydragel 6 CSF KitCFF · Traditional | 10/07/1998SE |
| K974854 | Hydragel-Mini Lipo Kit-Pn 4093, Hydragel Lipo Kit-Pn 4007, Hydragel Lipo Maxi Kit-Pn 4207JHO · Traditional | 10/07/1998SE |
| K972591 | Hydragel Bence Jones Kit/Maxi Kit Hydragel Bence Jones/Hydragel 2/4 Bence Jones KitJKM · Traditional | 03/04/1998SE |
| K972015 | Hydragel 7,15,30, Chol-Hdl KitLBT · Traditional | 10/27/1997SE |
| K963844 | Hydragel 15 HB A1C KitLCP · Traditional | 04/22/1997SE |
| K960029 | Hydrasys Agarose Gel Electrophoresis Apparatus/Hydragel 15,30 Protein KitCEF · Traditional | 07/17/1996SE |
Questions and answers
When was Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E) Hemoglobin(E), Mini Acid(E) Hemo) cleared by the FDA?
Hydragel Hemoglobin(E), Mini Hemoglobin(E), 7 Hemoglobin(E), 15 Hemoglobin(E), Acid(E) Hemoglobin(E), Mini Acid(E) Hemo) (K991362) received a 510(k) decision of Substantially Equivalent on June 21, 1999, 68 days after the submission was received.
What is the product code of K991362?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.