ENCORE TEST STRIPS
FDA 510(k) clearance K923018 · decided 1992-09-23
Clearance details
- K-number
- K923018
- Device name
- ENCORE TEST STRIPS
- Applicant
- Heraeus Kulzer, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-06-23
- Decision date
- 1992-09-23
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- CFR
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mishawaka, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.