hema-screen SPECIFIC Gold
FDA 510(k) clearance K171484 · decided 2017-06-14
Clearance details
- K-number
- K171484
- Device name
- hema-screen SPECIFIC Gold
- Applicant
- Immunostics Inc.,
- Decision
- Substantially Equivalent
- Date received
- 2017-05-22
- Decision date
- 2017-06-14
- Days to decision
- 23 days
- Clearance type
- Special
- Product code
- KHE
- Device class
- 2
- Regulation number
- 864.6550
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Ocean, NJ, US
- Third-party review
- No
- Expedited review
- No
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| IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 (K100031) | Ind Diagnostic, Inc. | 2010-07-19 |
| BIOSIGN IFOBTEST, BIOSIGN FECAL OCCULT BLOOD TEST (K100817) | Princeton BioMeditech Corp. | 2010-07-01 |
| HEMOCCULT ICT (K080812) | Beckman Coulter, Inc. | 2008-06-25 |
Recalls involving this device
No recalls on record reference this clearance.