Intersect Systems, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 21
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K021636 | ALBUMIN REAGENT | July 17, 2002 |
| K011972 | DIRECT BILIRUBIN REAGENT | August 27, 2001 |
| K011692 | HOMOGENEOUS ENZYMIC HOMOCYSTEINE REAGENT | July 25, 2001 |
| K003892 | TOTAL BILIRUBIN REAGENT | February 20, 2001 |
| K983937 | DUAL VIAL CREATININE REAGENT | January 6, 1999 |
| K974833 | CK-NAC REAGENT | February 13, 1998 |
| K941807 | INTERSECT SYSTEMS' NON-MERCURIC CHLORIDE REAGENT | September 14, 1994 |
| K932888 | INTERSECT SYSTEMS DIRECT AMYLASE REAGENT | January 31, 1994 |
| K934039 | INTERSECT SYSTEMS HDL CHOLESTEROL REAGENT SET | November 16, 1993 |
| K932267 | ENZYMATIC CO2 REAGENT, MODIFICATION | September 24, 1993 |
| K913225 | URINE/CSF MICROPROTEIN REAGENT | October 11, 1991 |
| K911297 | CHLORIDE REAGENT | April 16, 1991 |
| K881169 | CARBON DIOXIDE REAGENT | April 28, 1988 |
| K873835 | GLUCOSE-HK REAGENT | November 24, 1987 |
| K871979 | GAMMA GLUTAMYLTRANSFERASE REAGENT | June 11, 1987 |
| K870828 | INTERSECT SYSTEMS ENZYMATIC CHOLESTEROL REAGENT | March 13, 1987 |
| K870827 | INTERSECT SYSTEMS TRIGLYCERIDE-GPO REAGENT | March 13, 1987 |
| K870616 | GLUCOSE OXIDASE REAGENT | March 6, 1987 |
| K841148 | MINI PECG-MODIFICATION | April 17, 1984 |
| K832883 | MINI-PECG | December 6, 1983 |