The following data is part of a premarket notification filed by Pharmacia Fine Chemicals with the FDA for Phytohaemagglutinin.
Device ID | K790239 |
510k Number | K790239 |
Device Name: | PHYTOHAEMAGGLUTININ |
Classification | Kit, Culture, Chromosome |
Applicant | PHARMACIA FINE CHEMICALS 803 N. Front St. Suite 3 McHenry, IL 60050 |
Product Code | KIQ |
Subsequent Product Code | New |
CFR Regulation Number | 864.2260 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1979-02-01 |
Decision Date | 1979-03-08 |