Glycohemosure HBA1C Control
FDA 510(k) K032791 · Quantimetrix Corp.
510(k) numberK032791
Submission
- Device name
- Glycohemosure HBA1C Control
- Applicant
- Quantimetrix Corp.
Redondo Beach, CA, US - Received
- September 8, 2003
- Decision date
- October 30, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGM – Control, Hemoglobin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8625
- Specialty
- Hematology
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| K993321 | R&D Hgb/Glc Whole Blood ControlGGM · Traditional | R&D Systems, Inc. | 11/12/1999SE |
| K964052 | Hemocue HemotrolGGM · Traditional | Direct Solutions | 11/06/1996SE |
| K963908 | Hemocue HemolinGGM · Traditional | Direct Solutions | 10/16/1996SE |
| K921681 | Criterion, Hemocue B-Hemoglobin ControlGGM · Traditional | Isolab, Inc. | 11/17/1992SE |
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Questions and answers
When was Glycohemosure HBA1C Control cleared by the FDA?
Glycohemosure HBA1C Control (K032791) received a 510(k) decision of Substantially Equivalent on October 30, 2003, 52 days after the submission was received.
What is the product code of K032791?
The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.