American Diagnostic Corp.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 39
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K162589 | Adscope 658 Electronic Stethoscope | March 10, 2017 |
| K093495 | OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS | November 19, 2010 |
| K060321 | ADSCOPE 657BK ELECTRONIC STETHOSCOPE, MODEL 657BK | May 15, 2006 |
| K012304 | ADC 656 ELECTRONIC STETHOSCOPE | November 1, 2001 |
| K962655 | ANEROID AND MERCURIAL SPHYGMOMANOMETERS | January 27, 1997 |
| K940686 | ELECTRONIC THERMOMETERS | July 8, 1994 |
| K935944 | PROSCOPES AND ADSCOPES | March 3, 1994 |
| K932145 | COAGULATION REFERENCE PLASMA, NORMAL | October 18, 1993 |
| K894169 | BIOTEL MICROALBUMINURIA (TM) | September 18, 1989 |
| K893608 | ACTICHROME ATIII KIT | June 23, 1989 |
| K884940 | RELLPLATE C KIT, RELLPLATE C BULK PLATES | March 13, 1989 |
| K884941 | ACTICLOT C KIT | March 13, 1989 |
| K870500 | MAJOR QUALITY GLUCOSE AND KETONES URINE TEST | March 6, 1987 |
| K855239 | BIOTEL (TM)/ DIABETES | June 13, 1986 |
| K855238 | BIOTEL (TM)/UTI | May 9, 1986 |
| K855237 | BIOTEL (TM)/ KIDNEY | May 6, 1986 |
| K832493 | QUINIDINE FLUORESCENT IMMUNOASSAY | September 12, 1983 |
| K831377 | IGE RADIOIMMUNOASSAY KIT | June 2, 1983 |
| K823062 | KENAMYCIN FLUORESCENT IMMUNOASSAY FIA | November 10, 1982 |
| K822941 | NETILMICIN FLUORESCENT IMMUNOASSAY | October 26, 1982 |