Miles Laboratories, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 158
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K880605 | LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER | May 26, 1988 |
| K874909 | MICRO-BUMINTEST REAGENT TABLETS | April 28, 1988 |
| K875079 | MODIFIED SERALYZER ALT/SGPT REAG. STRIPS & MODULE | April 5, 1988 |
| K871835 | GLUCOMETER QC BLOOD METER, AMES GLUCO SYSTEM PRINT | December 22, 1987 |
| K872120 | SERALYZER III BLOOD CHEMISTRY ANALYZER | October 28, 1987 |
| K873304 | CLINITEK AUTO 2000 REAGENT CASSETTE (LEUKOCYTES) | September 11, 1987 |
| K872634 | CUTTER PUREFLO PLUS IV FILTER | August 4, 1987 |
| K870214 | MODIFIED SALTEX REAGENT STRIPS | June 29, 1987 |
| K870752 | SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS | April 14, 1987 |
| K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST | February 18, 1987 |
| K864530 | SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. | February 18, 1987 |
| K865020 | SERA-TEK THYROGLOBULIN ANTIBODY TEST | February 2, 1987 |
| K863842 | SERALYZER ARIS CARBAMAZEPINE STRIPS/MODU/CALI/CONT | January 14, 1987 |
| K861844 | GLUCOFACTS DATA MANAGEMENT SYSTEM | August 12, 1986 |
| K861779 | GLUCOFACTS DATA PRINTER | August 8, 1986 |
| K861778 | CLINIFACTS 200 DATA MANAGEMENT SYSTEM | July 2, 1986 |
| K861303 | GLUCOMETER II IMPROVED REFLECTANCE PHOTOMETER | July 2, 1986 |
| K855202 | GLUCOMETER M BLOOD GULCOSE METER | July 2, 1986 |
| K855203 | GLUCOLET AUTOMATIC LANCING DEVICE FOR OBT. BLOOD | February 11, 1986 |
| K855040 | SERALYZER TOTAL BILIRUBIN CALIBRATORS | January 22, 1986 |