PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
FDA 510(k) clearance K903914 · decided 1990-10-03
Clearance details
- K-number
- K903914
- Device name
- PARAMAX CEREBROSPINAL FLUID/URINE PROTEIN BLANK
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-08-24
- Decision date
- 1990-10-03
- Days to decision
- 40 days
- Clearance type
- Traditional
- Product code
- JGQ
- Device class
- 2
- Regulation number
- 862.1635
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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| HITACHI S TEST REAGENT CARTRIDGE TOTAL PROTEIN (TP) AND ALBUMIN (ALB) (K131051) | Hitachi Chemical Diagnostics, Inc. | 2013-06-07 |
| ROCHE/HITACHI URINARY/CSF PROTEIN WITH MODEL(S) CAT #11877801 (K072638) | Roche Diagnostics Corp. | 2007-10-19 |
| TOTAL PROTEIN URINE/CSF GEN.3 (K071239) | Roche Diagnostics | 2007-09-14 |
| UPRO (K981295) | Abbott Laboratories | 1998-10-01 |
| UPRO (K981682) | Abbott Laboratories | 1998-09-21 |
| TRACE MICROPROTEIN REAGENT (K925794) | Trace America, Inc. | 1993-03-29 |
| URINARY/CSF PROTEIN (K913615) | Boehringer Mannheim Corp. | 1991-09-13 |
| EMDS(TM) CEREBROSPINAL FLUID PROTEIN, #67668/95 (K901083) | Em Diagnostic Systems, Inc. | 1990-04-16 |
| CEREBROSPINAL FLUID PROTEIN TESTPACK, #67668/95 (K863478) | Em Diagnostic Systems, Inc. | 1986-10-29 |
| SOMAS COOMASIE BLUE TOTAL PROTEIN ASSAY (K842134) | Somas Medical Industries, Inc. | 1984-07-06 |
| ACA URINARY PROTEIN ANALYTICAL TEST PACK (K822231) | E.I. Dupont DE Nemours & Co., Inc. | 1982-09-30 |
| CSF TOTAL PROTEIN TEST SET #0340 (K780110) | Stanbio Laboratory | 1978-03-03 |
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 |