Gelman Glyco-Phore Buffer
FDA 510(k) K820518 · Gelman Sciences, Inc.
510(k) numberK820518
Submission
- Device name
- Gelman Glyco-Phore Buffer
- Applicant
- Gelman Sciences, Inc.
Mchenry, IL, US - Received
- February 25, 1982
- Decision date
- April 9, 1982
- 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 |
| K830804 | Labile Removing Hemolyzing ReagentJBD · Traditional | Corning Medical & Scientific | 05/04/1983SE |
| K813395 | Cellulose Acetate-Citrate Agar HemogloJBD · Traditional | Helena Laboratories | 12/31/1981SE |
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| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
Questions and answers
When was Gelman Glyco-Phore Buffer cleared by the FDA?
Gelman Glyco-Phore Buffer (K820518) received a 510(k) decision of Substantially Equivalent on April 9, 1982, 43 days after the submission was received.
What is the product code of K820518?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.