Sigma Procedure No. 465 for Deter. of Fructosamine
FDA 510(k) K884184 · Sigma Diagnostics, Inc.
510(k) numberK884184
Submission
- Device name
- Sigma Procedure No. 465 for Deter. of Fructosamine
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 4, 1988
- Decision date
- March 28, 1989
- 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 Sigma Procedure No. 465 for Deter. of Fructosamine cleared by the FDA?
Sigma Procedure No. 465 for Deter. of Fructosamine (K884184) received a 510(k) decision of Substantially Equivalent on March 28, 1989, 175 days after the submission was received.
What is the product code of K884184?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.