STRATUS(R) AUTOMATED SAMPLE HANDLER
FDA 510(k) clearance K911712 · decided 1991-05-15
Clearance details
- K-number
- K911712
- Device name
- STRATUS(R) AUTOMATED SAMPLE HANDLER
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1991-04-17
- Decision date
- 1991-05-15
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- JQW
- Device class
- 1
- Regulation number
- 862.2750
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BD VIPER INSTRUMENT (K023955) | Becton, Dickinson & CO | 2003-06-24 |
| QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335) | Zenyx Scientific , Ltd. | 1998-04-30 |
| 2700 SAMPLE MANAGER (K980180) | Waters Corporation | 1998-02-12 |
| MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420) | Pharmacia, Inc. | 1997-06-30 |
| MINI SAMPLER PROCESSOR (K970616) | Cavro Scientific Instruments, Inc. | 1997-04-21 |
| GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687) | Nichols Institute Diagnostics | 1997-03-28 |
| MINI SAMPLE PROCESSOR (K962859) | Cavro Scientific Instruments, Inc. | 1996-10-29 |
| MICROLAB 4000, MICROLAB 4200 (K961896) | Hamilton Co. | 1996-08-16 |
| IMPACT (K961694) | Matrix Technologies Corp. | 1996-06-21 |
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
| ROBOCAP (K952025) | Pharmacia, Inc. | 1995-07-26 |
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 |