Atlas FDA

TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET

FDA 510(k) clearance K080811 · decided 2008-06-20

Clearance details

K-number
K080811
Device name
TINA-QUANT CYSTATIN C, CALIBRATOR F.A.S. CYSTATIN C AND CYSTATIN C ANDCYSTATIN C CONTROL SET
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2008-03-24
Decision date
2008-06-20
Days to decision
88 days
Clearance type
Traditional
Product code
NDY
Device class
2
Regulation number
862.1225
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