Company ยท US
Biochem International, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 1994. Name variants (Inc, Corp, punctuation) are merged.
28510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 6 |
| DQA | Oximeter | 4 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 3 |
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | 3 |
| CBZ | Analyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling | 2 |
| BZQ | Monitor, Breathing Frequency | 1 |
| CBF | Chamber, Hyperbaric | 1 |
| CBQ | Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration) | 1 |
| CBS | Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.) | 1 |
| CCC | Analyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling | 1 |
| CCL | Analyzer, Gas, Oxygen, Gaseous-Phase | 1 |
| DQO | Catheter, Intravascular, Diagnostic | 1 |
| DSK | Computer, Blood-Pressure | 1 |
| KGZ | Accessories, Catheter | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 11, 1994 | K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER Biochem International, Inc. | DQA |
| Dec 3, 1993 | K932389 | 8100 ANESTHETIC AGENT MONITOR Biochem International, Inc. | CBS |
| May 26, 1993 | K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE Biochem International, Inc. | DSK |
| Jan 7, 1993 | K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER Biochem International, Inc. | DQA |
| Aug 22, 1991 | K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP Biochem International, Inc. | DXN |
| Aug 22, 1991 | K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE Biochem International, Inc. | CCL |
| Sep 4, 1990 | K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR Biochem International, Inc. | DXN |
| Jul 27, 1990 | K901861 | BIOCHEM 9100 MULTIGAS MONITOR Biochem International, Inc. | CCK |
| Dec 20, 1989 | K893877 | BIOCHEM 3100 OXIMETER Biochem International, Inc. | DQO |
| Aug 31, 1989 | K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR Biochem International, Inc. | CBQ |
| Jun 15, 1989 | K890874 | BIOCHEM 520 BREATH INDICATOR Biochem International, Inc. | CCK |
| Dec 17, 1987 | K873856 | BIOCHEM 9090 CAPNOGRAPH/SAO2 Biochem International, Inc. | CCK |
| Dec 11, 1987 | K873959 | BIOCHEM 8800 CAPNOMETER Biochem International, Inc. | CCK |
| Apr 21, 1987 | K871133 | BIOCHEM 8090 CAPNOGRAPH Biochem International, Inc. | CCK |
| Mar 3, 1987 | K870163 | BIOCHEM MICROSPAN 1040 OXIMETER Biochem International, Inc. | DQA |
| Nov 7, 1986 | K863186 | BIOCHEM CO/OX 1000 Biochem International, Inc. | DQA |
| May 30, 1986 | K854333 | BIOCHEM 515 RESPIRATION MONITOR Biochem International, Inc. | BZQ |
| Oct 12, 1984 | K842303 | MICROSPAN -PH MONITOR Biochem International, Inc. | CBF |
| Apr 17, 1984 | K840918 | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT Biochem International, Inc. | KLK |
| Nov 16, 1981 | K812643 | LIFESPAN CO2 Biochem International, Inc. | CCK |
| Jun 12, 1981 | K811470 | LIFESPAN 100 Biochem International, Inc. | KLK |
| Feb 2, 1981 | K803260 | SENSOMAT MUSCLE/TISSUE PH Biochem International, Inc. | CBZ |
| Dec 22, 1980 | K803014 | SENSOMAT Biochem International, Inc. | CBZ |
| Aug 20, 1980 | K801657 | NON-INVASIVE, BLOOD PRESSURE MONITOR Biochem International, Inc. | DXN |
| Feb 5, 1980 | K800073 | TRANSCUTANEOUS OXYGEN MONITOR Biochem International, Inc. | |
| Jul 10, 1979 | K790597 | SENSOMAT SIDEARM ADAPTER Biochem International, Inc. | KGZ |
| Dec 26, 1978 | K781910 | MONITOR, SENSOMATIII OXYGEN Biochem International, Inc. | KLK |
| Sep 26, 1977 | K771722 | SENSOMAT Biochem International, Inc. | CCC |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||