Biodiagnostic Intl
Brea, CA, US
Biodiagnostic Intl appears in FDA device records in Brea, CA. FDA records list 11 510(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
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Biodiagnostic Intl between 1983 and 2004. The busiest year on record is 1984, with 3. The most recent is 2004, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 1 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 1 |
| 1987 | 1 |
| 1988 | 1 |
| 2004 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K031296 | LIQUI-HEME GLYCO A1C ASSAY | LCP | Substantially Equivalent | |
| K881430 | LIQUI-SERA SERUM ALCOHOL CONTROLS | JJX | Substantially Equivalent | |
| K874459 | LIQUI-SERA SPINAL FLUID CONTROL | JJY | Substantially Equivalent | |
| K863849 | LIQUI-SERA COMBO LIGAND/TDM CONTROLS | JJY | Substantially Equivalent | |
| K853906 | LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE) | JJY | Substantially Equivalent | |
| K853887 | LIQUI-SERA CHEM. MULTIPLE CALIBRATORS | JIT | Substantially Equivalent | |
| K842668 | LIQUI-HEME HEMOGLOBIN CALIBRATORS | KRZ | Substantially Equivalent | |
| K840618 | LIQUI-URA CHEMISTRY URINE CONTROLS | JJW | Substantially Equivalent | |
| K834398 | LIQUI-SERA TDM CALIBRATORS | DKB | Substantially Equivalent | |
| K834259 | LIQUI-URA TOXIC URINE CONTROL | DIF | Substantially Equivalent | |
| K831278 | LIQUI-SERA ANTICONVULSANTS CONTROLS | DIF | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- LCPAssay, Glycosylated Hemoglobin
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JITCalibrator, Secondary
- DKBCalibrators, Drug Mixture
- DIFDrug Mixture Control Materials
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JJWUrinalysis Controls (Assayed And Unassayed)
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