CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
FDA 510(k) clearance K032437 · decided 2003-10-08
Clearance details
- K-number
- K032437
- Device name
- CHEMSTRIP 5 OB, CHEMSTRIP 7 AND CHEMSTRIP 10 MD TEST STRIPS
- Applicant
- Roche Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-08-07
- Decision date
- 2003-10-08
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- JIL
- Device class
- 2
- Regulation number
- 862.1340
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 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 |