Company ยท US
Beckman-Diagnostic Systems Group
FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1994. 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 |
|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIG | Diazo Colorimetry, Bilirubin | 1 |
| DFT | Igm, Antigen, Antiserum, Control | 1 |
| DJG | Enzyme Immunoassay, Opiates | 1 |
| DKC | Alcohol Control Materials | 1 |
| DKZ | Enzyme Immunoassay, Amphetamine | 1 |
| JFJ | Catalytic Methods, Amylase | 1 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 1 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 1 |
| KHP | Acid, Lactic, Enzymatic Method | 1 |
| LCM | Enzyme Immunoassay, Phencyclidine | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 12, 1994 | K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS Beckman-Diagnostic Systems Group | DFT |
| Dec 7, 1994 | K944605 | CX PHENCYCLIDINE REAGENT FOR SYNSCHRON CX SYSTEM Beckman-Diagnostic Systems Group | LCM |
| Dec 7, 1994 | K944604 | CX AMPHETAMINES REAGENT FOR SYNCHRON CX SYSTEMS Beckman-Diagnostic Systems Group | DKZ |
| Nov 30, 1994 | K944606 | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS Beckman-Diagnostic Systems Group | DJG |
| Nov 2, 1994 | K942676 | SYNCHRON CX3 DELTA Beckman-Diagnostic Systems Group | JJF |
| Jul 6, 1994 | K934293 | BECKMAN PANCREATIC AMYLASE (PAMY) REAGENT Beckman-Diagnostic Systems Group | JFJ |
| Apr 26, 1994 | K934068 | BECKMAN DIRECT BILIRUBIN REAGENT Beckman-Diagnostic Systems Group | CIG |
| Apr 15, 1994 | K936184 | VIGIL PRX CHEMISTRY CONTROL Beckman-Diagnostic Systems Group | JJY |
| Nov 9, 1993 | K934271 | BECKMAN SYNCHRON LACTATE REAGENT Beckman-Diagnostic Systems Group | KHP |
| Oct 28, 1993 | K934046 | BECKMAN CHOLESTEROL REAGENT Beckman-Diagnostic Systems Group | CHH |
| Oct 27, 1993 | K934467 | BECKMAN CX AMMONIA/ALCOHOL CONTROL Beckman-Diagnostic Systems Group | DKC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||