EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.— 510(k) K821963
Substantially EquivalentIntl. Immunoassay Laboratories, Inc.
FDA 510(k) clearance K821963 for EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT., Substantially Equivalent on 1982-07-27. Applicant: Intl. Immunoassay Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Intl. Immunoassay Laboratories, Inc.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code GGP
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