IMMUNOCCULT EIA TEST KIT
FDA 510(k) clearance K871143 · decided 1988-07-08
Clearance details
- K-number
- K871143
- Device name
- IMMUNOCCULT EIA TEST KIT
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-23
- Decision date
- 1988-07-08
- Days to decision
- 473 days
- Clearance type
- Traditional
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Santa Clara, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.