GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
FDA premarket approval P990026/S007 · decided 2001-10-25
Approval details
- PMA number
- P990026
- Supplement
- S007
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- GLUCOWATCH AUTOMATIC GLUCOSE BIOGRAPHER
- Generic name
- GLUCOSE OXIDASE, GLUCOSE
- Applicant
- Animas Corp.
- Date received
- 2001-08-28
- Decision date
- 2001-10-25
- Days to decision
- 58 days
- Decision code
- APPR
- Product code
- CGA
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- West Chester, PA
- Statement
- APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT CYGNUS, INC., REDWOOD, CALIFORNIA.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SYMPHONY GLUCOSE MANAGEMENT SYSTEM (K080639) | Animas Corp. | 2008-06-24 |
| EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE (K080587) | Animas Corp. | 2008-05-15 |
| EZMANAGER MAX DIABETES MANAGEMENT SOFTWARE (K063674) | Animas Corp. | 2007-03-30 |
| ANIMAS MODEL IR1250 INSULIN INFUSION PUMP (K042873) | Animas Corp. | 2004-12-10 |
| MODEL IR 1200 INSULIN PUMP (K032257) | Animas Corp. | 2003-10-16 |
| EZMANAGER PLUS (K022394) | Animas Corp. | 2003-06-05 |
| ANIMUS EZSERTER INFUSION SET INSERTER (K021700) | Animas Corp. | 2002-06-04 |
| MODEL R1000 IR INSULIN PUMP, EZLINK SOFTWARE, SERMON SOFTWARE, R1000 IR DOWNLOAD CRADLE, AND SERIAL INTERFACE ADAPTOR DO (K021439) | Animas Corp. | 2002-05-29 |