Beckman B-4 Teb Buffer Kit
FDA 510(k) K791290 · Beckman Instruments, Inc.
510(k) numberK791290
Submission
- Device name
- Beckman B-4 Teb Buffer Kit
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- July 10, 1979
- Decision date
- August 3, 1979
- 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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| K931465 | Rep Alkaline HB-15 #3196,-8 #3197,-4 3198JBD · Traditional | Helena Laboratories | 07/06/1993SE |
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| 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 Beckman B-4 Teb Buffer Kit cleared by the FDA?
Beckman B-4 Teb Buffer Kit (K791290) received a 510(k) decision of Substantially Equivalent on August 3, 1979, 24 days after the submission was received.
What is the product code of K791290?
The FDA product code is JBD – System, Analysis, Electrophoretic Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7440.