STERICHEK BLOOD LEAK REAGENT STRIPS
FDA 510(k) clearance K042322 · decided 2004-12-07
Clearance details
- K-number
- K042322
- Device name
- STERICHEK BLOOD LEAK REAGENT STRIPS
- Applicant
- Hach Company
- Decision
- Substantially Equivalent
- Date received
- 2004-08-26
- Decision date
- 2004-12-07
- Days to decision
- 103 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 |
| SERIM BLOOD LEAK TEST STRIP-2 (K012115) | Serim Research Corp. | 2001-11-30 |
| SERIM BLOOD LEAK TEST STRIP (K990206) | Serim Research Corp. | 1999-04-21 |
Recalls involving this device
No recalls on record reference this clearance.