NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
FDA 510(k) clearance K943780 · decided 1994-10-31
Clearance details
- K-number
- K943780
- Device name
- NEGATIVE CONTROL STRIPS FOR URINALYSIS (CHEX-STIX, CLINITEK AUTO 2000, CLINITEX ATLAS)
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-08-03
- Decision date
- 1994-10-31
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- JJW
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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