PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
FDA 510(k) clearance K901141 · decided 1990-04-09
Clearance details
- K-number
- K901141
- Device name
- PARAMAX 520, PARAMAX 720 AND PARAMAX 720ZX
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-03-13
- Decision date
- 1990-04-09
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- JJC
- Device class
- 1
- Regulation number
- 862.2150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, 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 |
|---|---|---|
| AVL OMNI ANALYZER (K945915) | Avl Scientific Corp. | 1995-04-05 |
| NOVA 16 ANALYZER (K945584) | Nova Biomedical Corp. | 1995-02-08 |
| OPERA SYSTEM (K943376) | Miles, Inc. | 1994-09-14 |
| TECHNICON RA-2000(TM) SYSTEM (K901410) | Technicon Instruments Corp. | 1990-07-17 |
| RFA/2 RAPID FLOW ANALYZER W/COMPUTER (K890332) | Alpkem Corp. | 1989-02-17 |
| AMRESCO FLOW PAC RANDOM ACCESS LIQUID #4901030 (K881056) | American Research Products Co. | 1988-11-15 |
| TECHNICON SMAC 3 SYSTEM (K875105) | Technicon Instruments Corp. | 1988-02-16 |
| TECHNICON RA-XT(TM) SYSTEM IMMUNOASSAYS (K870998) | Technicon Instruments Corp. | 1987-05-26 |
| TECHNICON RA-XT SYSTEM WITH ANALYTES (K862561) | Technicon Instruments Corp. | 1986-10-20 |
| TECHNICON RA-500 SYSTEM (K854345) | Technicon Instruments Corp. | 1985-11-26 |
| REPLACEMENT REAGENTS FOR SMAC II SYSTEMS (K852306) | Methodist Hospital of Memphis | 1985-08-02 |
| LANCER ANALYZER CUPS (K833157) | Sherwood Medical Co. | 1983-12-08 |
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 |