Company ยท US
Disease Detection International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1988 to 1994. Name variants (Inc, Corp, punctuation) are merged.
20510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 6 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 |
| LFZ | Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 1 |
| GQO | Antisera, Cf, Herpesvirus Hominis 1,2 | 1 |
| GTZ | Antisera, All Groups, Streptococcus Spp. | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| LYF | Pneumocystis Carinii | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 25, 1994 | K943252 | PRO-STEP LH OVULATION PREDICTION TEST Disease Detection International, Inc. | CEP |
| Jun 15, 1993 | K925303 | PRO-STEP PT HCG Disease Detection International, Inc. | JHI |
| Jan 13, 1993 | K925125 | PRO-STEP HCG Disease Detection International, Inc. | JHI |
| Jul 19, 1991 | K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT Disease Detection International, Inc. | JHI |
| Sep 5, 1990 | K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST Disease Detection International, Inc. | LFX |
| Aug 9, 1990 | K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT Disease Detection International, Inc. | LGC |
| Dec 1, 1989 | K895912 | IMMUNOCARD HCG II-S TEST KIT Disease Detection International, Inc. | JHI |
| Nov 29, 1989 | K896109 | IMMUNOCARD STREP A TEST Disease Detection International, Inc. | GTZ |
| Apr 10, 1989 | K884249 | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT Disease Detection International, Inc. | LGD |
| Apr 10, 1989 | K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT Disease Detection International, Inc. | LFZ |
| Apr 10, 1989 | K884247 | MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT Disease Detection International, Inc. | LFX |
| Apr 10, 1989 | K884246 | MODIFIED DDI SEROCARD HERPES IGG TEST KIT Disease Detection International, Inc. | LGC |
| Mar 14, 1989 | K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY Disease Detection International, Inc. | LYF |
| Jan 30, 1989 | K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST Disease Detection International, Inc. | LCX |
| Jul 8, 1988 | K881709 | IMMUNOCARD(TM) HCG II TEST KIT Disease Detection International, Inc. | JHI |
| May 23, 1988 | K875366 | THE DDI SERODOT HERPES IGG TEST KIT Disease Detection International, Inc. | GQO |
| May 13, 1988 | K875361 | SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT Disease Detection International, Inc. | LFZ |
| Apr 21, 1988 | K875363 | SERODOT TOXOPLASMA IGG TEST KIT Disease Detection International, Inc. | LGD |
| Apr 5, 1988 | K880410 | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT Disease Detection International, Inc. | JHI |
| Mar 23, 1988 | K875368 | THE DDI SERODOT RUBELLA IGG TEST KIT Disease Detection International, Inc. | LFX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||