IMMUNOCCULT EIA TEST KIT— 510(k) K871143
Substantially EquivalentIntl. Immunoassay Laboratories, Inc.
FDA 510(k) clearance K871143 for IMMUNOCCULT EIA TEST KIT, Substantially Equivalent on 1988-07-08. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Product code
- Code KHE
- Device class
- Class 2
- Regulation
- 21 CFR 864.6550
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Santa Clara, CA, US
Recent devices under product code KHE
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