PARAMAX AMYLASE REAGENT
FDA 510(k) clearance K873520 · decided 1987-11-23
Clearance details
- K-number
- K873520
- Device name
- PARAMAX AMYLASE REAGENT
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1987-09-01
- Decision date
- 1987-11-23
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- CJA
- Device class
- 2
- Regulation number
- 862.1070
- 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 |
|---|---|---|
| MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) (K895555) | Hichem Diagnostics | 1989-12-22 |
| AMYLASE REAGENT KIT FOR ASTRA SYSTEMS (K884226) | A-Kem, Inc. | 1988-12-09 |
| WAKO(TM) AUTOKIT AMYLASE (K883059) | Wako Chemicals USA, Inc. | 1988-08-30 |
| ALPHA AMYLASE (K863052) | J. D. Assoc. | 1986-09-09 |
| AMYLASE LTS (K862640) | Electro-Nucleonics Laboratories, Inc. | 1986-09-09 |
| AMYLASE REAGENT SET (MODIFIED CARAWAY) (K860530) | Sterling Diagnostics, Inc. | 1986-02-28 |
| AMYLASE REAGENT CS-726 (K844168) | Fisher Scientific Co., LLC | 1984-11-20 |
| ASTRA SYSTEMS AMYLASE REAGENT KIT (K843529) | Beckman Instruments, Inc. | 1984-10-11 |
| AMYLASE REAGENT SET-MODIFIED CARAWAY (K833864) | Sterling Biochemical, Inc. | 1984-01-13 |
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 |