510(k) K790239
K790239 is an FDA 510(k) premarket notification submitted by Pharmacia Fine Chemicals for the device "PHYTOHAEMAGGLUTININ". The FDA issued a decision of Substantially Equivalent on March 8, 1979. The device falls under product code KIQ (Kit, Culture, Chromosome), a Class I device regulated under 21 CFR 864.2260.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 8, 1979
- Date Received
- February 1, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Kit, Culture, Chromosome
- Device Class
- Class I
- Regulation Number
- 864.2260
- Review Panel
- PA
- Submission Type