DADE(R) PROTEIN C ABNORMAL CONTRAL
FDA 510(k) clearance K911885 · decided 1991-06-11
Clearance details
- K-number
- K911885
- Device name
- DADE(R) PROTEIN C ABNORMAL CONTRAL
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1991-04-29
- Decision date
- 1991-06-11
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- GGC
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Baxter Healthcare Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HEMOSIL LA POSITIVE CONTROL (K102552) | Instrumentation Laboratory CO | 2011-04-05 |
| SPECIALTY ASSAYED CONTROL-2 (K100103) | Helena Laboratories | 2010-12-15 |
| PLASMACON N, PLASMACON L-1, PLASMACON L-2 (K062306) | R2 Diagnostics, Inc. | 2007-03-16 |
| STA - CONTROL LA 1+2 (K061803) | Diagnostica Stago, Inc. | 2006-07-28 |
| CRYOCHECK WEAK LUPUS POSITIVE CONTROL (K032804) | Precision Biologic | 2003-11-03 |
| CONTROL PLASMA P (K023312) | Dade Behring, Inc. | 2002-11-01 |
| LYPHOCHEK HEMOSTASIS, MODELS 798, 799 (K020878) | Bio-Rad | 2002-04-15 |
| SIGMA DIAGNOSTICS ACCUCLOT LA CONTROL (K020109) | Sigma Diagnostics, Inc. | 2002-02-06 |
| K-ASSAY D-DIMER CONTROLS (K012422) | Kamiya Biomedical Co. | 2001-08-21 |
| SIGMA DIANOSTICS AUTO D-DIMER CONTROL LEVEL 2, MODEL A5217 (K003329) | Sigma Diagnostics, Inc. | 2001-03-01 |
| GRADIPLASMA LA HIGH, GRADIPLASMA LA LOW MODELS LAHP-1, LAHP-05, LALP-1, LALP-05 (K993332) | Gradipore , Ltd. | 2000-02-16 |
| COAGULATION CONTROL LEVEL 2 (ABNORMAL) (K984130) | Pacific Hemostasis | 1998-12-01 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |