Lyphochek Hemoglobin Alc Linearity Set
FDA 510(k) K003030 · Bio-Rad
510(k) numberK003030
Submission
- Device name
- Lyphochek Hemoglobin Alc Linearity Set
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- September 28, 2000
- Decision date
- November 29, 2000
- 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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| K070546 | Lyphochek Diabetes ControlGGM · Traditional | Bio-Rad Laboratories | 04/02/2007SE |
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| 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 Lyphochek Hemoglobin Alc Linearity Set cleared by the FDA?
Lyphochek Hemoglobin Alc Linearity Set (K003030) received a 510(k) decision of Substantially Equivalent on November 29, 2000, 62 days after the submission was received.
What is the product code of K003030?
The FDA product code is GGM – Control, Hemoglobin, a Class II (moderate risk) device regulated under 21 CFR 864.8625.