CIBA CORNING ACS PSA IMMUNOASSAY
FDA premarket approval P920030/S002 · decided 1998-12-08
Approval details
- PMA number
- P920030
- Supplement
- S002
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CIBA CORNING ACS PSA IMMUNOASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Bayer Healthcare, LLC
- Date received
- 1998-04-20
- Decision date
- 1998-12-08
- Days to decision
- 232 days
- Decision code
- APPR
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
- Statement
- Approval for the addition of a new indication for use. The device, as modified, will be marketed under the trade names ACS:180 PSA2 assay and ACS:Centaur PSA2 assay and is indicated for the following indications for use: as an aid in the detection of prostate cancer when used in conjunction with digital rectal examination (DRE) in men aged 50 years or older. Prostatic biopsy is required for the diagnosis of cancer; and as aid in the management of patients with prostate cancer.
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| CONTOUR NEXT EZ BLOOD GLUCOSE METER (K130265) | Bayer Healthcare, LLC | 2014-06-23 |
| CONTOUR NEXT BLOOD GLUCOSE METER (K121190) | Bayer Healthcare, LLC | 2012-07-26 |
| CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) (K110587) | Bayer Healthcare, LLC | 2012-03-28 |
| DIDGET WORLD REPORTS (K093930) | Bayer Healthcare, LLC | 2010-03-12 |
| DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 (K090628) | Bayer Healthcare, LLC | 2009-12-04 |
| A1CNOW+ (10 TEST KIT, PROFESSIONAL USE) MODEL 3024, A1CNOW+(20 TEST KIT, PROFESSIONAL USE) MODEL 3021, A1CNOW SELF CHEC (K090413) | Bayer Healthcare, LLC | 2009-05-14 |