Protein-Bound Glucose Assayn Kit
FDA 510(k) K930823 · Diagnostic Specialties
510(k) numberK930823
Submission
- Device name
- Protein-Bound Glucose Assayn Kit
- Applicant
- Diagnostic Specialties
Metuchen, NJ, US - Received
- February 17, 1993
- Decision date
- August 19, 1993
- 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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| K831180 | Pregna-Cert, Slide Pregnancy TestJHJ · Traditional | 05/27/1983SE |
| K823109 | Generic Pregnancy TestLCX · Traditional | 11/10/1982SE |
| K813608 | Potassium Reagent SetCEJ · Traditional | 01/22/1982SE |
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Questions and answers
When was Protein-Bound Glucose Assayn Kit cleared by the FDA?
Protein-Bound Glucose Assayn Kit (K930823) received a 510(k) decision of Substantially Equivalent on August 19, 1993, 183 days after the submission was received.
What is the product code of K930823?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.