MACRALP(A) ENZYME IMMUNOASSAY KIT
FDA 510(k) clearance K971157 · decided 1998-04-15
Clearance details
- K-number
- K971157
- Device name
- MACRALP(A) ENZYME IMMUNOASSAY KIT
- Applicant
- Strategic Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-03-28
- Decision date
- 1998-04-15
- Days to decision
- 383 days
- Clearance type
- Traditional
- Product code
- JHO
- Device class
- 1
- Regulation number
- 862.1475
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.