Glycotest II Glyhb Assay Kit
FDA 510(k) K895661 · Pierce Chemical Co.
510(k) numberK895661
Submission
- Device name
- Glycotest II Glyhb Assay Kit
- Applicant
- Pierce Chemical Co.
Rockford, IL, US - Received
- September 20, 1989
- Decision date
- December 7, 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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| 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 |
More from Alfa Wassermann Diagnostic Technologies, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K831837 | Clinovative II Diagnostic KitLCP · Traditional | 08/01/1983SE |
| K821360 | Glyco-Gel Test KitLCP · Traditional | 06/02/1982SE |
| K820279 | Glyco-Gel Test KitLCP · Traditional | 04/08/1982SE |
| K781897 | Stat Kit, MicroproteinCEK · Traditional | 01/10/1979SE |
| K780827 | Uric Acid Rapid Stat KitKNK · Traditional | 06/13/1978SE |
| K780826 | Bilirubin Rapid Stat KitCIG · Traditional | 05/26/1978SE |
| K780825 | Triglyceride C-37 Rapid Stat KitJGY · Traditional | 05/26/1978SE |
| K780512 | Auto/Stat KitCGA · Traditional | 05/03/1978SE |
| K780331 | Cholesterol Rapid Slat Kit HDLCHH · Traditional | 04/06/1978SE |
Questions and answers
When was Glycotest II Glyhb Assay Kit cleared by the FDA?
Glycotest II Glyhb Assay Kit (K895661) received a 510(k) decision of Substantially Equivalent on December 7, 1989, 78 days after the submission was received.
What is the product code of K895661?
The FDA product code is LCP – Assay, Glycosylated Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.7470.