Company ยท CA
Ind Diagnostic, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2003 to 2012. Name variants (Inc, Corp, punctuation) are merged.
8510(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 | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| JIL | Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | 1 |
| KHE | Reagent, Occult Blood | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
| NGJ | Test, Nitrite, Urinary, Non-Quantitative, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 17, 2012 | K103037 | IND URINARY TRACT INFECTION (UTI) TEST STRIPS Ind Diagnostic, Inc., CA | NGJ |
| Jul 19, 2010 | K100031 | IND ONE STEP FECAL OCCULT BLOOD TEST MODEL 440-10 Ind Diagnostic, Inc., CA | KHE |
| Mar 1, 2007 | K063390 | URINE CHEMISTRY ANALYZER UR-50 Ind Diagnostic, Inc. | JIL |
| Aug 7, 2006 | K060810 | ONE STEP DRUG TEST - AMP/MET/MOR/THC/COC Ind Diagnostic, Inc., CA | DKZ |
| Dec 16, 2005 | K052694 | ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES. Ind Diagnostic, Inc., CA | JHI |
| Nov 30, 2005 | K052662 | ONE STEP FSH MENOPAUSAL TEST Ind Diagnostic, Inc., CA | CGJ |
| May 16, 2005 | K050741 | IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT Ind Diagnostic, Inc., CA | JHI |
| Jan 3, 2003 | K023638 | CASSETTE/URINE HCG Ind Diagnostic, Inc., CA | LCX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||