Liquichek Diabetes Control, Level 1,2,3,4
FDA 510(k) K052838 · Bio-Rad
510(k) numberK052838
Submission
- Device name
- Liquichek Diabetes Control, Level 1,2,3,4
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- October 7, 2005
- Decision date
- November 9, 2005
- 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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|---|---|---|---|
| K192842 | HemoTrol Duo Low, HemoTrol Duo Normal, HemoTrol Duo HighGGM · Traditional | Eurotrol B.V. | 11/15/2019SE |
| K182744 | HemoTrol WB - Low, HemoTrol WB - Normal, HemoTrol WB - HighGGM · Traditional | Eurotrol B.V. | 02/01/2019SE |
| K070546 | Lyphochek Diabetes ControlGGM · Traditional | Bio-Rad Laboratories | 04/02/2007SE |
| K070334 | R&D Sickle QC ControlGGM · Traditional | R&D Systems, Inc. | 03/29/2007SE |
| K032791 | Glycohemosure HBA1C ControlGGM · Traditional | Quantimetrix Corp. | 10/30/2003SE |
| K003030 | Lyphochek Hemoglobin Alc Linearity SetGGM · Traditional | Bio-Rad | 11/29/2000SE |
| 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 Liquichek Diabetes Control, Level 1,2,3,4 cleared by the FDA?
Liquichek Diabetes Control, Level 1,2,3,4 (K052838) received a 510(k) decision of Substantially Equivalent on November 9, 2005, 33 days after the submission was received.
What is the product code of K052838?
The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.