OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
FDA 510(k) clearance K961274 · decided 1996-07-05
Clearance details
- K-number
- K961274
- Device name
- OLYMPUS AU600 CLINICAL CHEMISTRY ANALYZER
- Applicant
- Olympus America, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-04-02
- Decision date
- 1996-07-05
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Melville, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Olympus America
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.