Note: 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. |
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Device | CEA-ROCHE(R) EIA |
Generic Name | SYSTEM, TEST, CARCINOEMBRYONIC ANTIGEN |
Regulation Number | 866.6010 |
Applicant | ROCHE DIAGNOSTICS GMBH 1080 U.S. HWY. 202 BRANCHBURG TOWNSHIP SOMERVILLE, NJ 08876-3771 |
PMA Number | P840027 |
Supplement Number | S005 |
Date Received | 04/11/1989 |
Decision Date | 05/01/1989 |
Withdrawal Date
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09/27/2007 |
Product Code |
DHX |
Advisory Committee |
Immunology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
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