510(k) K855214
K855214 is an FDA 510(k) premarket notification submitted by Whale Scientific, Inc. for the device "CAT-3 CATECHOLAMINE ASSAY KIT". The FDA issued a decision of Substantially Equivalent on March 14, 1986. The device falls under product code CHQ (Chromatographic/Fluorometric Method, Catecholamines), a Class I device regulated under 21 CFR 862.1165. Whale Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 14, 1986
- Date Received
- December 30, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chromatographic/Fluorometric Method, Catecholamines
- Device Class
- Class I
- Regulation Number
- 862.1165
- Review Panel
- CH
- Submission Type