ABSORBANCE (ABS) TEST PAK
FDA 510(k) clearance K854784 · decided 1985-12-19
Clearance details
- K-number
- K854784
- Device name
- ABSORBANCE (ABS) TEST PAK
- Applicant
- Diagnostic Systems
- Decision
- Substantially Equivalent
- Date received
- 1985-11-29
- Decision date
- 1985-12-19
- Days to decision
- 20 days
- Clearance type
- Traditional
- Product code
- JIT
- Device class
- 2
- Regulation number
- 862.1150
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Gibbstown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.