510(k) K780455
K780455 is an FDA 510(k) premarket notification submitted by Whale Scientific, Inc. for the device "QUANTITATIVE DETERMINATION OF PORPHYRINS". The FDA issued a decision of Substantially Equivalent on July 27, 1978. The device falls under product code JKJ (Fluorometric Measurement, Porphyrins), a Class I device regulated under 21 CFR 862.1595. Whale Scientific, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 27, 1978
- Date Received
- March 20, 1978
- 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