Beckman Diatrac Hemoglobin a Electrophoresis Kit
FDA 510(k) K905709 · Beckman Instruments, Inc.
510(k) numberK905709
Submission
- Device name
- Beckman Diatrac Hemoglobin a Electrophoresis Kit
- Applicant
- Beckman Instruments, Inc.
Brea, CA, US - Received
- December 21, 1990
- Decision date
- September 23, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCP – Assay, Glycosylated Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7470
- Specialty
- Hematology
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Questions and answers
When was Beckman Diatrac Hemoglobin a Electrophoresis Kit cleared by the FDA?
Beckman Diatrac Hemoglobin a Electrophoresis Kit (K905709) received a 510(k) decision of Substantially Equivalent on September 23, 1991, 276 days after the submission was received.
What is the product code of K905709?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.