BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
FDA 510(k) clearance K800357 · decided 1980-04-16
Clearance details
- K-number
- K800357
- Device name
- BI-LEVEL ASSAYED CARD. DRUG CONT., I,II
- Applicant
- Ortho Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1980-02-20
- Decision date
- 1980-04-16
- Days to decision
- 56 days
- Clearance type
- Traditional
- Product code
- LAS
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.