Hemosil la Positive Control
FDA 510(k) K102552 · Instrumentation Laboratory CO
510(k) numberK102552
Submission
- Device name
- Hemosil la Positive Control
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- September 7, 2010
- Decision date
- April 5, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGC – Control, Plasma, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
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| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
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| K223090 | GEM Premier ChemSTATCGA · Special | 01/27/2023SE |
| K223402 | HemosIL von Willebrand Factor AntigenGGP · Special | 12/09/2022SE |
| K213464 | HemosIL Liquid Anti-XaKFF · Special | 10/04/2022SE |
| K213426 | HemosIL ReadiPlasTinGJS · Traditional | 08/16/2022SE |
Questions and answers
When was Hemosil la Positive Control cleared by the FDA?
Hemosil la Positive Control (K102552) received a 510(k) decision of Substantially Equivalent on April 5, 2011, 210 days after the submission was received.
What is the product code of K102552?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.