Binax Equate(R) Glycohemoglobin 3 Minute Test Kit
FDA 510(k) K912748 · Binax, Inc.
510(k) numberK912748
Submission
- Device name
- Binax Equate(R) Glycohemoglobin 3 Minute Test Kit
- Applicant
- Binax, Inc.
S. Portland, ME, US - Received
- June 21, 1991
- Decision date
- October 31, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 Binax Equate(R) Glycohemoglobin 3 Minute Test Kit cleared by the FDA?
Binax Equate(R) Glycohemoglobin 3 Minute Test Kit (K912748) received a 510(k) decision of Substantially Equivalent on October 31, 1991, 132 days after the submission was received.
What is the product code of K912748?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.