SERIM BLOOD LEAK TEST STRIP-2
FDA 510(k) clearance K012115 · decided 2001-11-30
Clearance details
- K-number
- K012115
- Device name
- SERIM BLOOD LEAK TEST STRIP-2
- Applicant
- Serim Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-07-06
- Decision date
- 2001-11-30
- Days to decision
- 147 days
- Clearance type
- Traditional
- Product code
- FJD
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Elkhart, 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.
| Record | Firm | Date |
|---|---|---|
| E-Z CHEK BLOOD LEAK TEST STRIPS (K123805) | Reprocessing Products Corp | 2013-03-20 |
| STERICHEK BLOOD LEAK REAGENT STRIPS (K042322) | Hach Company | 2004-12-07 |
| SERIM BLOOD LEAK TEST STRIP (K990206) | Serim Research Corp. | 1999-04-21 |
Recalls involving this device
No recalls on record reference this clearance.