AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
FDA 510(k) clearance K895465 · decided 1989-12-27
Clearance details
- K-number
- K895465
- Device name
- AMDEV LYTENING 2Z SODIUM/POTASSIUM/LITHIUM ANALYZE
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-09-11
- Decision date
- 1989-12-27
- Days to decision
- 107 days
- Clearance type
- Traditional
- Product code
- JIH
- Device class
- 2
- Regulation number
- 862.3560
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- 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 |
|---|---|---|
| MODIFICATION TO: INSTAREAD LITHIUM SYSTEM (K050338) | Akers Biosciences, Inc. | 2005-03-04 |
| INSTAREAD LITHIUM SYSTEM (K031579) | Akers Laboratories, Inc. | 2003-12-19 |
| DIMENSION LITHIUM (LI) FLEX REAGENT CARTRIDGE, MODEL DF 132 (K011033) | Dade Behring, Inc. | 2001-06-07 |
| KODAK EKTACHEM DTSC II SLIDES (LI) (K934106) | Eastman Kodak Company | 1994-04-25 |
| KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (LI) (K924488) | Eastman Kodak Company | 1993-01-26 |
| MODEL 654 ANALYZER (K921403) | Ciba Corning Diagnostics Corp. | 1992-07-30 |
| TDX(R) LITES(TM) LITHIUM (K894328) | Abbott Laboratories | 1989-11-13 |
| POTASSIUM DILUENT (K830636) | Shaban Mfg. Co. | 1983-04-05 |
| LITHIUM DILUENT (1500 MM/E) (K800039) | Gilford Diagnostics | 1980-01-21 |
| FLAME PHOTOMETER MODEL 460 (K771303) | Corning Medical & Scientific | 1977-08-22 |
| FLAME PHOTOMETER MOLEL 4600, KDA (K770824) | American Monitor Corp. | 1977-07-15 |
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 |