Company ยท US
Biodiagnostic Intl
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 2004. Name variants (Inc, Corp, punctuation) are merged.
11510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 3 |
| DIF | Drug Mixture Control Materials | 2 |
| DKB | Calibrators, Drug Mixture | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJW | Urinalysis Controls (Assayed And Unassayed) | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 1 |
| LCP | Assay, Glycosylated Hemoglobin | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2004 | K031296 | LIQUI-HEME GLYCO A1C ASSAY Biodiagnostic Intl | LCP |
| Jul 8, 1988 | K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS Biodiagnostic Intl | JJX |
| Dec 29, 1987 | K874459 | LIQUI-SERA SPINAL FLUID CONTROL Biodiagnostic Intl | JJY |
| Nov 24, 1986 | K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS Biodiagnostic Intl | JJY |
| Oct 4, 1985 | K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) Biodiagnostic Intl | JJY |
| Sep 30, 1985 | K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS Biodiagnostic Intl | JIT |
| Mar 5, 1985 | K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS Biodiagnostic Intl | KRZ |
| Apr 4, 1984 | K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS Biodiagnostic Intl | JJW |
| Feb 3, 1984 | K834398 | LIQUI-SERA TDM CALIBRATORS Biodiagnostic Intl | DKB |
| Jan 30, 1984 | K834259 | LIQUI-URA TOXIC URINE CONTROL Biodiagnostic Intl | DIF |
| May 27, 1983 | K831278 | LIQUI-SERA ANTICONVULSANTS CONTROLS Biodiagnostic Intl | DIF |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||