EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
FDA 510(k) clearance K021781 · decided 2002-08-30
Clearance details
- K-number
- K021781
- Device name
- EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
- Applicant
- Chay Medical, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-05-30
- Decision date
- 2002-08-30
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CGA
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Calistoga, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Chay Medical
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 |
|---|---|---|
| ABL90 FLEX PLUS System (K252488) | Radiometer Medicals Aps | 2026-05-01 |
| YSI 2900C Biochemistry Analyzer (K210933) | Ysi, Inc. | 2024-09-30 |
| EasyStat 300 (K220328) | Medica Corporation | 2024-07-26 |
| Cholestech LDX ™ System (K223179) | Alere San Diego, Inc. | 2023-09-20 |
| i-STAT G cartridge with the i-STAT 1 System (K223755) | Abbott Point of Care, Inc. | 2023-09-11 |
| i-STAT CG8+ cartridge with the i-STAT 1 System (K223710) | Abbott Point of Care, Inc. | 2023-07-28 |
| GEM Premier ChemSTAT (K223090) | Instrumentation Laboratory CO | 2023-01-27 |
| Nova Primary Glucose Analyzer System (K203549) | Nova Biomedical Corporation | 2022-10-18 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K210958) | Abbott Point of Care, Inc. | 2021-08-13 |
| Stat Profile Prime Plus Analyzer System (K200349) | Nova Biomedical Corporation | 2020-03-13 |
| i-STAT CHEM8+ cartridge with the i-STAT 1 System (K183678) | Abbott Point of Care, Inc. | 2020-02-07 |
| VITROS XT Chemistry Products GLU-Ca Slides (K190520) | Ortho-Clinical Diagnostics, Inc. | 2019-04-03 |
Recalls involving this device
No recalls on record reference this clearance.