Atlas FDA

PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS

FDA 510(k) clearance K040280 · decided 2004-03-11

Clearance details

K-number
K040280
Device name
PRECINORM PROTEINS IN URINE/CSF PRECIPATH PROTEINS IN URINE/CSR CONTROLS
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2004-02-06
Decision date
2004-03-11
Days to decision
34 days
Clearance type
Traditional
Product code
JJY
Device class
1
Regulation number
862.1660
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S046)Roche Diagnostics Corp.2026-04-29
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S045)Roche Diagnostics Corp.2026-04-29
Elecsys total PSA assay (P990056/S045)Roche Diagnostics Corp.2026-02-27
Elecsys free PSA assay (P000027/S044)Roche Diagnostics Corp.2026-02-27
ELECSYS FREE PSA IMMUNOASSAY/CALSET/CALCHECK (P000027/S043)Roche Diagnostics Corp.2025-05-27
ELECSYS TOTAL PSA IMMUNOASSAY AND TOTAL PSA CALSET (P990056/S044)Roche Diagnostics Corp.2025-05-27
Elecsys Anti-HBc II (P100031/S033)Roche Diagnostics Corp.2025-05-22
Elecsys Anti-HBc II (P100032/S023)Roche Diagnostics Corp.2025-05-22