Hemoglobin A2 Testing System
FDA 510(k) K771649 · Isolab, Inc.
510(k) numberK771649
Submission
- Device name
- Hemoglobin A2 Testing System
- Applicant
- Isolab, Inc.
Mchenry, IL, US - Received
- August 29, 1977
- Decision date
- October 7, 1977
- 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 |
| 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 |
More from Gelman Sciences, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951014 | Isolab's T4 Test KitKLI · Traditional | 10/18/1996SE |
| K950481 | Neonatal Chemistry System, Galactose Test KitJIA · Traditional | 02/01/1996SE |
| K943547 | Phenylalanine Test KitJNB · Traditional | 01/26/1996SE |
| K950803 | Isolab's GALACTOSE-1-PHOSPHATE Uridyl Tranferase Test Kits 800, 4000 SampleJJT · Traditional | 09/21/1995SE |
| K950415 | Fluoroscan NeonatalKHO · Traditional | 09/05/1995SE |
| K942276 | Quik-Sep Quantitative Hemoglobin S AssayGIQ · Traditional | 01/20/1995SE |
| K942222 | Quik-Sep Quantitive Hemoglobin S ControlsJCM · Traditional | 01/20/1995SE |
| K944185 | IsoscanJQT · Traditional | 11/17/1994SE |
| K934013 | Resolve Systems Alkaline Phosphatase Test KitCIN · Traditional | 04/26/1994SE |
| K923153 | Hemocard, Hemoglobin C AssayMLL · Traditional | 01/27/1994SE |
Questions and answers
When was Hemoglobin A2 Testing System cleared by the FDA?
Hemoglobin A2 Testing System (K771649) received a 510(k) decision of Substantially Equivalent on October 7, 1977, 39 days after the submission was received.
What is the product code of K771649?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.