510(k) K903609
K903609 is an FDA 510(k) premarket notification submitted by Immunotech Corp. for the device "SEROTONIN ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on October 22, 1990. The device falls under product code CDA (Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin), a Class I device regulated under 21 CFR 862.1390. Immunotech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 22, 1990
- Date Received
- August 9, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Acid, Nitrous And Nitrosonaphthol, 5-Hydroxyindole Acetic Acid/Serotonin
- Device Class
- Class I
- Regulation Number
- 862.1390
- Review Panel
- CH
- Submission Type