Rotag Fructosamine (Glycated Protein) Assay
FDA 510(k) K900718 · Roche Diagnostic Systems, Inc.
510(k) numberK900718
Submission
- Device name
- Rotag Fructosamine (Glycated Protein) Assay
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- February 14, 1990
- Decision date
- June 12, 1990
- 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 Rotag Fructosamine (Glycated Protein) Assay cleared by the FDA?
Rotag Fructosamine (Glycated Protein) Assay (K900718) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 118 days after the submission was received.
What is the product code of K900718?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.