BIOSTATOR GLUCOSE CONTROLLER
FDA premarket approval P800032 · decided 1981-05-28
Approval details
- PMA number
- P800032
- Trade name
- BIOSTATOR GLUCOSE CONTROLLER
- Generic name
- Controller, closed-loop blood glucose
- Applicant
- Miles Laboratories, Inc.
- Date received
- 1980-06-05
- Decision date
- 1981-05-28
- Days to decision
- 357 days
- Decision code
- APPR
- Product code
- LHE
- Advisory committee
- General Hospital
- Expedited review
- No
- Location
- Elkhart, IN
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER (K880605) | Miles Laboratories, Inc. | 1988-05-26 |
| MICRO-BUMINTEST REAGENT TABLETS (K874909) | Miles Laboratories, Inc. | 1988-04-28 |
| MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE (K875079) | Miles Laboratories, Inc. | 1988-04-05 |
| GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT (K871835) | Miles Laboratories, Inc. | 1987-12-22 |
| SERALYZER III BLOOD CHEMISTRY ANALYZER (K872120) | Miles Laboratories, Inc. | 1987-10-28 |
| CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) (K873304) | Miles Laboratories, Inc. | 1987-09-11 |
| CUTTER PUREFLO PLUS IV FILTER (K872634) | Miles Laboratories, Inc. | 1987-08-04 |
| MODIFIED SALTEX REAGENT STRIPS (K870214) | Miles Laboratories, Inc. | 1987-06-29 |