Disease Detection International, Inc.
Irvine, CA, US
Disease Detection International, Inc. appears in FDA device records in Irvine, CA. FDA records list 20 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 20
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 20 510(k) clearances for Disease Detection International, Inc. between 1988 and 1994. The busiest year on record is 1989, with 8. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 6 |
| 1989 | 8 |
| 1990 | 2 |
| 1991 | 1 |
| 1993 | 2 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K943252 | PRO-STEP LH OVULATION PREDICTION TEST | CEP | Substantially Equivalent | |
| K925303 | PRO-STEP PT HCG | JHI | Substantially Equivalent | |
| K925125 | PRO-STEP HCG | JHI | Substantially Equivalent | |
| K911826 | IMMUNOCARD HCG ONE STEP (I-S) TEST KIT | JHI | Substantially Equivalent | |
| K902571 | MODIFICATION OF SEROCARD RUBELLA IGG TEST | LFX | Substantially Equivalent | |
| K903070 | SEROCARD HSV IGG ANTIBODY TEST KIT | LGC | Substantially Equivalent | |
| K895912 | IMMUNOCARD HCG II-S TEST KIT | JHI | Substantially Equivalent | |
| K896109 | IMMUNOCARD STREP A TEST | GTZ | Substantially Equivalent | |
| K884249 | MODIFIED DDI SEROCARD TOXOPLASMA IGG TEST KIT | LGD | Substantially Equivalent | |
| K884248 | MODIFIED DDI SEROCARD CMV IGG TEST KIT | LFZ | Substantially Equivalent | |
| K884247 | MODIFIED DDI SEROCARD RUBELLA IGG TEST KIT | LFX | Substantially Equivalent | |
| K884246 | MODIFIED DDI SEROCARD HERPES IGG TEST KIT | LGC | Substantially Equivalent | |
| K884047 | FLUOROSLIDE PNEUMOCYSTIS CARINII (IFA) ASSAY | LYF | Substantially Equivalent | |
| K883430 | PREGNA-CARD(TM) A VISUAL HOME PREGNANCY TEST | LCX | Substantially Equivalent | |
| K881709 | IMMUNOCARD(TM) HCG II TEST KIT | JHI | Substantially Equivalent | |
| K875366 | THE DDI SERODOT HERPES IGG TEST KIT | GQO | Substantially Equivalent | |
| K875361 | SERODOT CMV (CYTOMEGALOVIRUS) IGG TEST KIT | LFZ | Substantially Equivalent | |
| K875363 | SERODOT TOXOPLASMA IGG TEST KIT | LGD | Substantially Equivalent | |
| K880410 | HUMAN CHORIONIC GONADOTROPIN VISUAL TEST KIT | JHI | Substantially Equivalent | |
| K875368 | THE DDI SERODOT RUBELLA IGG TEST KIT | LFX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- LFZEnzyme Linked Immunoabsorbent Assay, Cytomegalovirus
- LGCEnzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific
- LFXEnzyme Linked Immunoabsorbent Assay, Rubella
- LGDEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- LYFPneumocystis Carinii
- CEPRadioimmunoassay, Luteinizing Hormone
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain