POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
FDA 510(k) clearance K040332 · decided 2004-06-16
Clearance details
- K-number
- K040332
- Device name
- POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZER
- Applicant
- Arkray, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-02-10
- Decision date
- 2004-06-16
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- JJF
- Device class
- 1
- Regulation number
- 862.2170
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Arkray
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 |
|---|---|---|
| ETI-MAX 3000 (K052794) | DiaSorin, Inc. | 2006-03-31 |
| LIGHTCYCLER INSTRUMENT VERSION 1.2 (K033734) | Roche Diagnostics Corp. | 2003-12-17 |
| PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZER (K013654) | Precision Systems, Inc. | 2002-06-05 |
| ROCHE COBAS TAQMAN ANALYZER (K012966) | Roche Molecular Systems, Inc. | 2002-02-01 |
| CARESIDE ANALYZER (K993634) | Careside, Inc. | 1999-12-02 |
| VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA (K973628) | Vital Scientific N.V. | 1998-03-13 |
| CARESIDE ANALYZER (K980056) | Exigent Diagnostics, Inc. | 1998-03-06 |
| MAGO AUTOMATED EIA PROCESSOR (K973177) | Diamedix Corp. | 1997-10-09 |
| SYNERMED IR 200 CHEMISTRY ANALYZER (K971491) | Synermed, Inc. | 1997-06-26 |
| ROCHE COBAS AMPLICOR ANALYZER (K964506) | Roche Molecular Systems, Inc. | 1997-05-21 |
| WINMAX SOFTWARE SYSTEMS (K965103) | Diagnostic Products Corp. | 1997-05-09 |
| HCL - 200 BIOCHEMISTRY ANALYZER (K964409) | Hcl Laboratory Systems, Inc. | 1997-01-22 |
Recalls involving this device
No recalls on record reference this clearance.