PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
FDA 510(k) clearance K893508 · decided 1989-08-04
Clearance details
- K-number
- K893508
- Device name
- PROSTATE SPECIFIC ANTIGEN IMMUNOHISTOCHEMICAL ANTI
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-05-05
- Decision date
- 1989-08-04
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- JFH
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Bellevue, WA, US
- Third-party review
- No
- Expedited review
- No
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| HYBRITECH STRATUS PAP FLUOROMETRIC ENZYME IMMUNO (K921745) | Hybritech, Inc. | 1992-07-30 |
| MILENIA PAP IRMA CATALOG #: MKPA1, X (K902937) | Diagnostic Products Corp. | 1990-09-21 |
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| IRMA-COUNT(TM) PAP, (RKPA1, RKPA2) (K895723) | Diagnostic Products Corp. | 1989-10-31 |
| TECHNICON CHEM 1 SYSTEM ACID PHOS (PROSTATIC) (K884748) | Technicon Instruments Corp. | 1989-01-30 |
| ABBOTT PAP-EIA (K873903) | Abbott Laboratories | 1987-12-01 |
| TANDEM(R) M-PAK(TM) PAP IMMUNOENZYMETRIC ASSAY (K864945) | Hybritech, Inc. | 1987-01-05 |
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 |