CEA-ROCHE(R) EIA

FDA Premarket Approval P840027 S005

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceCEA-ROCHE(R) EIA
Generic NameSystem, Test, Carcinoembryonic Antigen
ApplicantROCHE DIAGNOSTICS GMBH
Date Received1989-04-11
Decision Date1989-05-01
PMAP840027
SupplementS005
Product CodeDHX 
Advisory CommitteeImmunology
Supplement TypeNormal 180 Day Track
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ROCHE DIAGNOSTICS GMBH 1080 U.s. Hwy. 202 branchburg Township somerville, NJ 08876-3771

Supplemental Filings

Supplement NumberDateSupplement Type
P840027Original Filing
S006 1989-04-11 Normal 180 Day Track
S005 1989-04-11 Normal 180 Day Track
S004 1988-10-27 Normal 180 Day Track
S003 1988-05-17 Normal 180 Day Track
S002 1986-08-19 Normal 180 Day Track
S001 1986-06-17 Special (immediate Track)

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.