Beckman-Diagnostic Systems Group
Brea, CA, US
Beckman-Diagnostic Systems Group 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 Beckman-Diagnostic Systems Group between 1993 and 1994. The busiest year on record is 1994, with 8. The most recent is 1994, with 8.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1993 | 3 |
| 1994 | 8 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | DFT | Substantially Equivalent | |
| K944605 | CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM | LCM | Substantially Equivalent | |
| K944604 | CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS | DKZ | Substantially Equivalent | |
| K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS | DJG | Substantially Equivalent | |
| K942676 | SYNCHRON CX3 DELTA | JJF | Substantially Equivalent | |
| K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT | JFJ | Substantially Equivalent | |
| K934068 | BECKMAN DIRECT BILIRUBIN REAGENT | CIG | Substantially Equivalent | |
| K936184 | VIGIL PRX CHEMISTRY CONTROL | JJY | Substantially Equivalent | |
| K934271 | BECKMAN SYNCHRON LACTATE REAGENT | KHP | Substantially Equivalent | |
| K934046 | BECKMAN CHOLESTEROL REAGENT | CHH | Substantially Equivalent | |
| K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL | DKC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KHPAcid, Lactic, Enzymatic Method
- DKCAlcohol Control Materials
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- JFJCatalytic Methods, Amylase
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- DKZEnzyme Immunoassay, Amphetamine
- DJGEnzyme Immunoassay, Opiates
- LCMEnzyme Immunoassay, Phencyclidine
- DFTIgm, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
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