Hbf-Quiplate Methodology
FDA 510(k) K780807 · Helena Laboratories
510(k) numberK780807
Submission
- Device name
- Hbf-Quiplate Methodology
- Applicant
- Helena Laboratories
Mchenry, IL, US - Received
- May 4, 1978
- Decision date
- June 2, 1978
- 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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|---|---|---|---|
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| 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 |
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Questions and answers
When was Hbf-Quiplate Methodology cleared by the FDA?
Hbf-Quiplate Methodology (K780807) received a 510(k) decision of Substantially Equivalent on June 2, 1978, 29 days after the submission was received.
What is the product code of K780807?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.