510(k) K821963
K821963 is an FDA 510(k) premarket notification submitted by Intl. Immunoassay Laboratories, Inc. for the device "EIA-F8 ENZYMEIMMUNOASSAY KIT FOR QUANT.". The FDA issued a decision of Substantially Equivalent on July 27, 1982. The device falls under product code GGP (Test, Qualitative And Quantitative Factor Deficiency), a Class II device regulated under 21 CFR 864.7290. Intl. Immunoassay Laboratories, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1982
- Date Received
- July 1, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Qualitative And Quantitative Factor Deficiency
- Device Class
- Class II
- Regulation Number
- 864.7290
- Review Panel
- HE
- Submission Type