Eltrachem Diatrac Glycosylated Hemoglob
FDA 510(k) K834294 · Emd Chemicals, Inc.
510(k) numberK834294
Submission
- Device name
- Eltrachem Diatrac Glycosylated Hemoglob
- Applicant
- Emd Chemicals, Inc.
Mchenry, IL, US - Received
- December 8, 1983
- Decision date
- January 24, 1984
- 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 Eltrachem Diatrac Glycosylated Hemoglob cleared by the FDA?
Eltrachem Diatrac Glycosylated Hemoglob (K834294) received a 510(k) decision of Substantially Equivalent on January 24, 1984, 47 days after the submission was received.
What is the product code of K834294?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.