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.
Modifications to the hybritech tandem-e cea assay whith enhancements in the formualtion of the alkaline phosphatase-labeled anti-cea antibody conjugate and the addtion of the blocking reagent poly mak 33, a copolymer of intact and fab fragmented mouse anti-human ck-mm antibodies
| Device | TANDEM(R) E CEA IMMUNORADIOMETRIC ASSAY |
| Generic Name | System, Test, Carcinoembryonic Antigen |
| Applicant | HYBRITECH, INC. |
| Date Received | 1995-09-21 |
| Decision Date | 1996-03-07 |
| PMA | P840019 |
| Supplement | S012 |
| Product Code | DHX |
| Advisory Committee | Immunology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HYBRITECH, INC. 11095 Torreyana Rd. p.o. Box 269006 san Diego, CA 92126 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840019 | Original Filing | |
| S012 | 1995-09-21 | Normal 180 Day Track |
| S011 | 1992-11-25 | Normal 180 Day Track |
| S010 | 1991-09-05 | Normal 180 Day Track |
| S009 | 1990-03-14 | Normal 180 Day Track |
| S008 | 1989-11-09 | Normal 180 Day Track |
| S007 | 1989-08-18 | Normal 180 Day Track |
| S006 | 1987-02-09 | Normal 180 Day Track |
| S005 | 1986-09-17 | Normal 180 Day Track |
| S004 | 1986-03-20 | Normal 180 Day Track |
| S003 | 1985-08-23 | |
| S002 | 1985-03-29 | |
| S001 | 1984-08-01 |