Labile Removing Hemolyzing Reagent
FDA 510(k) K830804 · Corning Medical & Scientific
510(k) numberK830804
Submission
- Device name
- Labile Removing Hemolyzing Reagent
- Applicant
- Corning Medical & Scientific
Mchenry, IL, US - Received
- March 14, 1983
- Decision date
- May 4, 1983
- 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
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|---|---|---|---|
| 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 |
| K901143 | Rep Hemoglobin Ief Kits (Cat. No. 3250)JBD · Traditional | Helena Laboratories | 05/23/1990SE |
| 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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Questions and answers
When was Labile Removing Hemolyzing Reagent cleared by the FDA?
Labile Removing Hemolyzing Reagent (K830804) received a 510(k) decision of Substantially Equivalent on May 4, 1983, 51 days after the submission was received.
What is the product code of K830804?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.