ELECSYS FREE PSA CALSET
FDA premarket approval P000027/S017 · decided 2013-04-10
Approval details
- PMA number
- P000027
- Supplement
- S017
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ELECSYS FREE PSA CALSET
- Generic name
- Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions
- Applicant
- Roche Diagnostics Corp.
- Date received
- 2012-12-19
- Decision date
- 2013-04-10
- Days to decision
- 112 days
- Decision code
- APPR
- Product code
- MTG
- Advisory committee
- Immunology
- Expedited review
- No
- Location
- Indianapolis, IN
- Statement
- APPROVAL FOR A TRANSFER FROM PACKAGING LINE 20 IN BUILDING 398, TO PACKAGING LINE 19 IN BUILDING 493 WITHIN THE MANNHEIM, GERMANY SITE AND TO CHANGE THE BOX AND SPACER ELEMENT SIZE, MAIN AND SIDE LABEL SIZE, AND LABEL LAYOUT.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEM (K130138) | Roche Diagnostics Corp. | 2013-03-15 |
| ELECSYS CA 19-9 CALCHECK 5 (K101365) | Roche Diagnostics Corp. | 2010-10-05 |
| COBAS 8000 MODULAR SERIES ANALYZER (K100853) | Roche Diagnostics Corp. | 2010-09-09 |
| ACCU-CHEK ULTRFLEX INFUSION SET (K101196) | Roche Diagnostics Corp. | 2010-08-27 |
| AMPHETAMINES II ASSAY (K093664) | Roche Diagnostics Corp. | 2010-07-28 |
| ELECSYS INSULIN CALCHECK 5 (K101075) | Roche Diagnostics Corp. | 2010-06-11 |
| ELECSYS TESTOSTERONE II IMMUNOASSAY (K093421) | Roche Diagnostics Corp. | 2010-04-23 |
| ELECSYS TROPONIN T CALCHECK 5 (K092848) | Roche Diagnostics Corp. | 2010-03-19 |