Disease Detection International, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 20
- Inspections
- 0
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | October 25, 1994 |
| K925303 | PRO-STEP PT HCG | June 15, 1993 |
| K925125 | PRO-STEP HCG | January 13, 1993 |
| K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT | July 19, 1991 |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | September 5, 1990 |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | August 9, 1990 |
| K895912 | IMMUNOCARD HCG II-S TEST KIT | December 1, 1989 |
| K896109 | IMMUNOCARD STREP A TEST | November 29, 1989 |
| K884249 | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT | April 10, 1989 |
| K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT | April 10, 1989 |
| K884246 | MODIFIED DDI SEROCARD HERPES IGG TEST KIT | April 10, 1989 |
| K884247 | MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT | April 10, 1989 |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | March 14, 1989 |
| K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST | January 30, 1989 |
| K881709 | IMMUNOCARD(TM) HCG II TEST KIT | July 8, 1988 |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | May 23, 1988 |
| K875361 | SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT | May 13, 1988 |
| K875363 | SERODOT TOXOPLASMA IGG TEST KIT | April 21, 1988 |
| K880410 | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT | April 5, 1988 |
| K875368 | THE DDI SERODOT RUBELLA IGG TEST KIT | March 23, 1988 |