Specialty Assayed CONTROL-2
FDA 510(k) K100103 · Helena Laboratories
510(k) numberK100103
Submission
- Device name
- Specialty Assayed CONTROL-2
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- January 13, 2010
- Decision date
- December 15, 2010
- 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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Questions and answers
When was Specialty Assayed CONTROL-2 cleared by the FDA?
Specialty Assayed CONTROL-2 (K100103) received a 510(k) decision of Substantially Equivalent on December 15, 2010, 336 days after the submission was received.
What is the product code of K100103?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.