CLINITEK MICROALBUMIN REAGENT STRIPS
FDA 510(k) clearance K972706 · decided 1997-09-09
Clearance details
- K-number
- K972706
- Device name
- CLINITEK MICROALBUMIN REAGENT STRIPS
- Applicant
- Bayer Corp.
- Decision
- Substantially Equivalent
- Date received
- 1997-07-21
- Decision date
- 1997-09-09
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CJG
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Elkhart, IN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.