The following data is part of a premarket notification filed by Pharmacia, Inc. with the FDA for Allergans Pharmacia Cap Sys.rast Ria/feia.
Device ID | K911903 |
510k Number | K911903 |
Device Name: | ALLERGANS PHARMACIA CAP SYS.RAST RIA/FEIA |
Classification | System, Test, Radioallergosorbent (rast) Immunological |
Applicant | PHARMACIA, INC. PO.BOX 10087 New Brunswick, NJ 08906 |
Contact | Albert P.mayo |
Correspondent | Albert P.mayo PHARMACIA, INC. PO.BOX 10087 New Brunswick, NJ 08906 |
Product Code | DHB |
CFR Regulation Number | 866.5750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-04-29 |
Decision Date | 1991-08-12 |