Dade(R) Protein C Abnormal Contral
FDA 510(k) K911885 · Baxter Healthcare Corp
510(k) numberK911885
Submission
- Device name
- Dade(R) Protein C Abnormal Contral
- Applicant
- Baxter Healthcare Corp
Miami, FL, US - Received
- April 29, 1991
- Decision date
- June 11, 1991
- 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
Other 510(k)s with product code GGC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K102552 | Hemosil la Positive ControlGGC · Traditional | Instrumentation Laboratory CO | 04/05/2011SE |
| K100103 | Specialty Assayed CONTROL-2GGC · Traditional | Helena Laboratories | 12/15/2010SE |
| K062306 | Plasmacon N, Plasmacon L-1, Plasmacon L-2GGC · Traditional | R2 Diagnostics, Inc. | 03/16/2007SE |
| 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 |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs)DXQ · Traditional | 12/16/2025SE |
| K251640 | SIGMA Spectrum Infusion Pump with Master Drug LibraryFRN · Traditional | 07/28/2025SE |
| K251636 | Spectrum IQ Infusion System with Dose IQ Safety Software (3570009)FRN · Traditional | 07/28/2025SE |
| K243529 | Solution Administration SetsFPA · Traditional | 03/14/2025SE |
| K242339 | Intravascular Extension Sets and AccessoriesFPA · Traditional | 02/28/2025SE |
| K242390 | Novum IQ Syringe Pump (40800BAXUS)FRN · Special | 09/05/2024SE |
| K241564 | Actifuse ABX; Actifuse MIS; Actifuse Shape; ALTAPORE; ALTAPORE SHAPE; ALTAPORE MISMQV · Traditional | 08/02/2024SE |
| K230665 | Dose IQ Safety SoftwarePHC · Traditional | 03/29/2024SE |
| K211122 | Novum IQ Large Volume PumpFRN · Traditional | 03/29/2024SE |
| K231849 | MiniCap Extended Life PD Transfer Set with Twist Clamp - Code 5C4482A; MiniCap Extended…KDJ · Traditional | 03/12/2024SE |
Questions and answers
When was Dade(R) Protein C Abnormal Contral cleared by the FDA?
Dade(R) Protein C Abnormal Contral (K911885) received a 510(k) decision of Substantially Equivalent on June 11, 1991, 43 days after the submission was received.
What is the product code of K911885?
The FDA product code is GGC – Control, Plasma, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.5425.