BIOSTATOR GCIIS
FDA premarket approval P790028 · decided 1980-12-04
Approval details
- PMA number
- P790028
- Trade name
- BIOSTATOR GCIIS
- Generic name
- Controller, closed-loop blood glucose
- Applicant
- Bayer Healthcare
- Date received
- 1979-11-16
- Decision date
- 1980-12-04
- Days to decision
- 384 days
- Decision code
- APWD
- Product code
- LHE
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Mishawaka, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Contour Next USB Blood Glucose Monitoring System (K150942) | Bayer Healthcare | 2015-11-25 |
| Contour Next Control Solution (K151742) | Bayer Healthcare | 2015-09-23 |
| CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE MONITOR (K122370) | Bayer Healthcare | 2013-09-26 |
| CONTOUR NEXT USB BLOOD GLUCOSE MONITORING SYSTEM (K121087) | Bayer Healthcare | 2012-06-28 |
| CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER (K110894) | Bayer Healthcare | 2012-03-28 |
| CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM (K111268) | Bayer Healthcare | 2012-03-06 |
| CONTOUR USB BLOOD GLUCOSE METER, GLUCOSE TEST STRIPS; GLUCOFACTS DELUX DIABETES MANAGEMENT SYSTEM (K091820) | Bayer Healthcare | 2009-08-26 |
| ASCENSIA CONTOUR BLOOD GLUCOSE METER, MODEL 7151; REAGENT STRIP, MODEL 7080 (K062058) | Bayer Healthcare | 2006-09-11 |