510(k) K882823
K882823 is an FDA 510(k) premarket notification submitted by Cyberfluor, Inc. for the device "FIAGEN HGH FLUOROIMMUNOASSAY KIT". The FDA issued a decision of Substantially Equivalent on August 30, 1988. The device falls under product code CFL (Radioimmunoassay, Human Growth Hormone), a Class I device regulated under 21 CFR 862.1370. Cyberfluor, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 30, 1988
- Date Received
- July 8, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Human Growth Hormone
- Device Class
- Class I
- Regulation Number
- 862.1370
- Review Panel
- CH
- Submission Type