510(k) K772426
K772426 is an FDA 510(k) premarket notification submitted by Hycel, Inc. for the device "17-HYDROXY TEST". The FDA issued a decision of Substantially Equivalent on January 30, 1978. The device falls under product code CDB (Porter Silber Hydrazone, 17-Hydroxycorticosteroids), a Class I device regulated under 21 CFR 862.1385. Hycel, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1978
- Date Received
- December 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Porter Silber Hydrazone, 17-Hydroxycorticosteroids
- Device Class
- Class I
- Regulation Number
- 862.1385
- Review Panel
- CH
- Submission Type