Specialty Assayed CONTROL-2 Cat. No. 5302
FDA 510(k) K941872 · Helena Laboratories
510(k) numberK941872
Submission
- Device name
- Specialty Assayed CONTROL-2 Cat. No. 5302
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- April 18, 1994
- Decision date
- November 21, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | Helena Laboratories | 12/15/2010SE |
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| K061803 | Sta - Control la 1+2GGC · Traditional | Diagnostica Stago, Inc. | 07/28/2006SE |
| K032804 | Cryocheck Weak Lupus Positive ControlGGC · Traditional | Precision Biologic | 11/03/2003SE |
| K023312 | Control Plasma PGGC · Traditional | Dade Behring, Inc. | 11/01/2002SE |
| K020878 | Lyphochek Hemostasis, Models 798, 799GGC · Traditional | Bio-Rad | 04/15/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | Sigma Diagnostics, Inc. | 02/06/2002SE |
| K012422 | K-Assay D-Dimer ControlsGGC · Traditional | Kamiya Biomedical Co. | 08/21/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | Sigma Diagnostics, Inc. | 03/01/2001SE |
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| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | 12/15/2010SE |
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Questions and answers
When was Specialty Assayed CONTROL-2 Cat. No. 5302 cleared by the FDA?
Specialty Assayed CONTROL-2 Cat. No. 5302 (K941872) received a 510(k) decision of Substantially Equivalent on November 21, 1994, 217 days after the submission was received.
What is the product code of K941872?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.