ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
FDA 510(k) clearance K071255 · decided 2007-09-07
Clearance details
- K-number
- K071255
- Device name
- ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A
- Applicant
- Hyphen Biomed
- Decision
- Substantially Equivalent
- Date received
- 2007-05-04
- Decision date
- 2007-09-07
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- LCO
- Device class
- 2
- Regulation number
- 864.7695
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mason, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ZYMUTEST HIA IgG, in vitro diagnostic ELISA kit, Ref. RK040A recall (Z-2171-2026) | Aniara Diagnostica LLC | 2026-05-12 |
| ZYMUTEST HIA IgGAM. Model Number: RK040D. Qualitative screening assay for the detection of recall (Z-1062-2018) | Hyphen BioMed | 2018-03-15 |
| ZYMUTEST HIA MonoStrip IgGAM. Model Number: RK041D. Qualitative screening assay for the de recall (Z-1063-2018) | Hyphen BioMed | 2018-03-15 |