Hemoglobin Af/Sc Electrophoresis Control
FDA 510(k) K791030 · Beckman Instruments, Inc.
510(k) numberK791030
Submission
- Device name
- Hemoglobin Af/Sc Electrophoresis Control
- Applicant
- Beckman Instruments, Inc.
Mchenry, IL, US - Received
- June 4, 1979
- Decision date
- June 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPK – Mixture, Hematology Quality Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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| K120742 | XN CheckJPK · Traditional | Streck | 10/19/2012SE |
| K101578 | R&D Systems Body Fluid-I Hematology ControlJPK · Traditional | R&D Systems, Inc. | 04/28/2011SE |
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Questions and answers
When was Hemoglobin Af/Sc Electrophoresis Control cleared by the FDA?
Hemoglobin Af/Sc Electrophoresis Control (K791030) received a 510(k) decision of Substantially Equivalent on June 22, 1979, 18 days after the submission was received.
What is the product code of K791030?
The FDA product code is JPK – Mixture, Hematology Quality Control, a Class II (moderate risk) device regulated under 21 CFR 864.8625.