Biochem International, Inc.
Mchenry, IL, US
Biochem International, Inc. appears in FDA device records in Mchenry, IL. FDA records list 28 510(k) clearances between and , 5 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
- 28
- PMA records
- 5
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Biochem International, Inc. between 1977 and 1994. The busiest year on record is 1987, with 4. The most recent is 1994, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 1 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 3 |
| 1984 | 2 |
| 1986 | 2 |
| 1987 | 4 |
| 1989 | 3 |
| 1990 | 2 |
| 1991 | 2 |
| 1993 | 3 |
| 1994 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K920083 | BIOCHEM MODEL 3302 NEWOX2 OXIMETER | DQA | Substantially Equivalent | |
| K932389 | 8100 ANESTHETIC AGENT MONITOR | CBS | Substantially Equivalent | |
| K921388 | BIOCHEM 9100 MULTIGAS MONITOR IBP MODULE | DSK | Substantially Equivalent | |
| K920082 | BIOCHEM MODEL 3301 NEWOX1 OXIMETER | DQA | Substantially Equivalent | |
| K911351 | BIOCHEM 9100 MULTIGAS MONITOR TEMP/FIO1 MOD,NIBP | DXN | Substantially Equivalent | |
| K910381 | BIOCHEM TEMPERATURE/ FIO2 MODULE | CCL | Substantially Equivalent | |
| K903222 | BIOCHEM 6100 NON-INVASIVE MONITOR | DXN | Substantially Equivalent | |
| K901861 | BIOCHEM 9100 MULTIGAS MONITOR | CCK | Substantially Equivalent | |
| K893877 | BIOCHEM 3100 OXIMETER | DQO | Substantially Equivalent | |
| K892646 | BIOCHEM 8100 ANESTHETIC AGENT MONITOR | CBQ | Substantially Equivalent | |
| K890874 | BIOCHEM 520 BREATH INDICATOR | CCK | Substantially Equivalent | |
| K873856 | BIOCHEM 9090 CAPNOGRAPH/SAO2 | CCK | Substantially Equivalent | |
| K873959 | BIOCHEM 8800 CAPNOMETER | CCK | Substantially Equivalent | |
| K871133 | BIOCHEM 8090 CAPNOGRAPH | CCK | Substantially Equivalent | |
| K870163 | BIOCHEM MICROSPAN 1040 OXIMETER | DQA | Substantially Equivalent | |
| K863186 | BIOCHEM CO/OX 1000 | DQA | Substantially Equivalent | |
| K854333 | BIOCHEM 515 RESPIRATION MONITOR | BZQ | Substantially Equivalent | |
| K842303 | MICROSPAN -PH MONITOR | CBF | Substantially Equivalent | |
| K840918 | MICRO SPAN TRANSCUTANEOUS OXYGEN MONIT | KLK | Substantially Equivalent | |
| K812643 | LIFESPAN CO2 | CCK | Substantially Equivalent | |
| K811470 | LIFESPAN 100 | KLK | Substantially Equivalent | |
| K803260 | SENSOMAT MUSCLE/TISSUE PH | CBZ | Substantially Equivalent | |
| K803014 | SENSOMAT | CBZ | Substantially Equivalent | |
| K801657 | NON-INVASIVE, BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | |
| K800073 | TRANSCUTANEOUS OXYGEN MONITOR | Substantially Equivalent | ||
| K790597 | SENSOMAT SIDEARM ADAPTER | KGZ | Substantially Equivalent | |
| K781910 | MONITOR, SENSOMATIII OXYGEN | KLK | Substantially Equivalent | |
| K771722 | SENSOMAT | CCC | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KGZAccessories, Catheter
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CCCAnalyzer, Gas, Carbon-Dioxide, Partial Pressure, Blood-Phase, Indwelling
- CBQAnalyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- CCLAnalyzer, Gas, Oxygen, Gaseous-Phase
- CBZAnalyzer, Ion, Hydrogen-Ion (Ph), Blood-Phase, Indwelling
- DQOCatheter, Intravascular, Diagnostic
- CBFChamber, Hyperbaric
- DSKComputer, Blood-Pressure
- BZQMonitor, Breathing Frequency
- LKDMonitor, Carbon-Dioxide, Cutaneous
- KLKMonitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia
- DQAOximeter
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain