Helena Glycosylated Hemoglobin Quik Meth
FDA 510(k) K800857 · Helena Laboratories
510(k) numberK800857
Submission
- Device name
- Helena Glycosylated Hemoglobin Quik Meth
- Applicant
- Helena Laboratories
Walker, MI, US - Received
- April 15, 1980
- Decision date
- September 26, 1980
- 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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| K173127 | skyla Hi Hemoglobin A1c System (skyla Hi Analyzer and skyla Hi Hemoglobin A 1 c Reagent…LCP · Traditional | Skyla Corporation H.S.P.B | 09/25/2018SE |
| K170623 | ACE Hemoglobin A1c (HbA1c) ReagentLCP · Traditional | Alfa Wassermann Diagnostic Technologies, LLC | 02/27/2018SE |
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Questions and answers
When was Helena Glycosylated Hemoglobin Quik Meth cleared by the FDA?
Helena Glycosylated Hemoglobin Quik Meth (K800857) received a 510(k) decision of Substantially Equivalent on September 26, 1980, 164 days after the submission was received.
What is the product code of K800857?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.