Company ยท US
Diagnostic Specialties
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 1997. 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 |
|---|---|---|
| CEJ | Tetraphenyl Borate, Colorimetry, Potassium | 1 |
| CGA | Glucose Oxidase, Glucose | 1 |
| GIS | Test, Fibrinogen | 1 |
| JHJ | Agglutination Method, Human Chorionic Gonadotropin | 1 |
| JIQ | Turbidimetric Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| JIR | Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
| LCX | Kit, Test, Pregnancy, Hcg, Over The Counter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 2, 1997 | K971458 | ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT Diagnostic Specialties | JIQ |
| Aug 30, 1994 | K941001 | ENZIP IMMUNOTURBIDMETRIC FIBRINOGEN ASSAY KIT Diagnostic Specialties | GIS |
| Aug 19, 1993 | K930823 | PROTEIN-BOUND GLUCOSE ASSAYN KIT Diagnostic Specialties | LCP |
| Jul 30, 1992 | K922032 | ENZIP URINARY MICROALBUMIN TEST Diagnostic Specialties | JIR |
| May 27, 1983 | K831180 | PREGNA-CERT, SLIDE PREGNANCY TEST Diagnostic Specialties | JHJ |
| Nov 10, 1982 | K823109 | GENERIC PREGNANCY TEST Diagnostic Specialties | LCX |
| Jan 22, 1982 | K813608 | POTASSIUM REAGENT SET Diagnostic Specialties | CEJ |
| Dec 31, 1981 | K813412 | GLUCOSE ENZYME-COLOR REAGENT SET Diagnostic Specialties | CGA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||