510(k) K893038
K893038 is an FDA 510(k) premarket notification submitted by Helena Laboratories for the device "PROTOFLUOR Z". The FDA issued a decision of Substantially Equivalent on November 17, 1989. The device falls under product code JKJ (Fluorometric Measurement, Porphyrins), a Class I device regulated under 21 CFR 862.1595. Helena Laboratories has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 17, 1989
- Date Received
- April 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fluorometric Measurement, Porphyrins
- Device Class
- Class I
- Regulation Number
- 862.1595
- Review Panel
- CH
- Submission Type