Ind Diagnostic, Inc.
Delta, B.C., CA
Ind Diagnostic, Inc. appears in FDA device records in Delta, B.C., CA. FDA records list 8 510(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
- 8
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 8 510(k) clearances for Ind Diagnostic, Inc. between 2003 and 2012. The busiest year on record is 2005, with 3. The most recent is 2012, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2003 | 1 |
| 2005 | 3 |
| 2006 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS | NGJ | Substantially Equivalent | |
| K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 | KHE | Substantially Equivalent | |
| K063390 | URINE CHEMISTRY ANALYZER UR-50 | JIL | Substantially Equivalent | |
| K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC | DKZ | Substantially Equivalent | |
| K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. | JHI | Substantially Equivalent | |
| K052662 | ONE STEP FSH MENOPAUSAL TEST | CGJ | Substantially Equivalent | |
| K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT | JHI | Substantially Equivalent | |
| K023638 | CASSETTE/URINE HCG | LCX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DKZEnzyme Immunoassay, Amphetamine
- LCXKit, Test, Pregnancy, Hcg, Over The Counter
- JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- KHEReagent, Occult Blood
- NGJTest, Nitrite, Urinary, Non-Quantitative, Over The Counter
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain