PICCOLO TRIGLYCERIDES TEST SYSTEM
FDA 510(k) clearance K023639 · decided 2003-01-24
Clearance details
- K-number
- K023639
- Device name
- PICCOLO TRIGLYCERIDES TEST SYSTEM
- Applicant
- Abaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-10-30
- Decision date
- 2003-01-24
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JGY
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Union City, 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 |
|---|---|---|
| PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM (K120664) | Abaxis, Inc. | 2012-04-24 |
| BIOSCANNER TRIGLYCERIDES TEST STRIPS (K000586) | Polymer Technology Systems, Inc. | 2000-07-03 |
| BIOSCANNER TRIGLYCERIDES TEST STRIPS (K991894) | Polymer Technology Systems, Inc. | 2000-05-24 |
| TRIGLYCERIDES (K971005) | Derma Media Lab., Inc. | 1997-04-21 |
| TRIGLYCERIDES REAGENT (K954187) | Schiapparelli Biosystems, Inc. | 1995-10-23 |
| DNA TRIGLYCERIDE PROCEDURE (K941063) | Data Medical Associates, Inc. | 1994-07-20 |
| IL TEST(TM) TRIGLYCERIDE (K931116) | Instrumentation Laboratory CO | 1994-03-28 |
| CHOLESTECH LIPID MONITOR SYST, TRIGLYCERIDES TEST (K914033) | Cholestech Corp. | 1991-09-27 |
| TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (K905226) | Enzyme Technology, Inc. | 1990-12-11 |
| DMA TRIGLYCERIDE (GPO) PROCEDURE (K902202) | Data Medical Associates, Inc. | 1990-07-31 |
| TRIGLYCERIDE (GPO) TRINDER REAGENT (K894063) | Sigma Diagnostics, Inc. | 1989-09-07 |
| CLINISTAT TRIGLYCERIDES REAGENT TEST (K885134) | Heraeus Kulzer, Inc. | 1989-02-10 |
Recalls involving this device
No recalls on record reference this clearance.