Hemosil la Positive Control & Hemosil la Negative Control
FDA 510(k) K113211 · Instrumentation Laboratory CO
510(k) numberK113211
Submission
- Device name
- Hemosil la Positive Control & Hemosil la Negative Control
- Applicant
- Instrumentation Laboratory CO
Bedford, MA, US - Received
- October 31, 2011
- Decision date
- January 4, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GGN – Plasma, Coagulation Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5425
- Specialty
- Hematology
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Questions and answers
When was Hemosil la Positive Control & Hemosil la Negative Control cleared by the FDA?
Hemosil la Positive Control & Hemosil la Negative Control (K113211) received a 510(k) decision of Substantially Equivalent on January 4, 2012, 65 days after the submission was received.
What is the product code of K113211?
The FDA product code is GGN – Plasma, Coagulation Control, a Class II (moderate risk) device regulated under 21 CFR 864.5425.