CIBA CORNING ACS PSA IMMUNOASSAY
FDA premarket approval P920030 · decided 1998-12-08
Approval details
- PMA number
- P920030
- Trade name
- CIBA CORNING ACS PSA IMMUNOASSAY
- Generic name
- PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS
- Applicant
- Bayer Healthcare, LLC
- Date received
- 1992-06-26
- Decision date
- 1998-12-08
- Days to decision
- 2356 days
- Decision code
- APWD
- Product code
- LTJ
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Tarrytown, NY
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device) (K171802) | Bayer Healthcare, LLC | 2018-03-07 |
| ALEVE Direct Therapy (ALEVE Direct Therapy TENS device) (K152852) | Bayer Healthcare, LLC | 2015-12-22 |
| 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 |