K-ASSAY LP(A) CONTROLS
FDA 510(k) clearance K023853 · decided 2002-12-13
Clearance details
- K-number
- K023853
- Device name
- K-ASSAY LP(A) CONTROLS
- Applicant
- Kamiya Biomedical Co.
- Decision
- Substantially Equivalent
- Date received
- 2002-11-19
- Decision date
- 2002-12-13
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- DFC
- Device class
- 2
- Regulation number
- 866.5600
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Seattle, WA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Kamiya Biomedical Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Lipoprotein (a) Molarity Assay (K253069) | Diazyme Laboratories, Inc. | 2026-06-16 |
| Tina-quant Lipoprotein(a) Gen.2 Molarity (K241220) | Roche Diagnostics Operations | 2025-01-24 |
| Lp(a) Ultra (K211058) | SENTINEL CH. SpA | 2022-12-22 |
| Diazyme Lipoprotein (a) Assay (K180074) | Diazyme Laboratories, Inc. | 2018-03-22 |
| ADVIA CHEMISTRY LIPOPROTEIN(A) REAGENT ADVIA CHEMISTRY LIPOPROTEIN(A) CALIBRATOR (K123046) | Siemens Healthcare Diagnostics, Inc. | 2012-12-20 |
| COBAS C TINA-QUANT LIPOPROTEIN (A) GEN 2 ASSAY MODEL 05852625190; PRECISET LP (A) GEN 2 CALIFRATOR SET MODEL 05852641160 (K122722) | Roche Diagnostics | 2012-11-29 |
| DIAZYME LP(A) ASSAY (K082488) | General Atomics | 2009-01-13 |
| LIPOPROTEIN(A), LIPOPROTEIN(A) CALIBRATOR, LIPOPROTEIN (A) CONTROL, CONTROL HIGH (K063838) | Thermo Electron OY | 2007-09-27 |
| QUANTIA LA(A) (K050487) | Biokit, S.A. | 2005-04-26 |
| K-ASSAY LP(A) ASSAY (K021660) | Kamiya Biomedical Co. | 2002-07-25 |
| LP(A)-LATEX SEIKEN ASSAY KIT (K013359) | Denka Seiken'S | 2002-03-08 |
| N LATEX LP(A) (K013128) | Dade Behring, Inc. | 2002-01-18 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| K-Assay Lp(a) Control recall (Z-0940-04) | Kamiya Biomedical Company | 2004-07-20 |