Avl Scientific Corp.
Roswell, GA, US
Avl Scientific Corp. appears in FDA device records in Roswell, GA. FDA records list 33 510(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
- 33
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 33 510(k) clearances for Avl Scientific Corp. between 1982 and 2000. The busiest year on record is 1994, with 4. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 1 |
| 1986 | 3 |
| 1987 | 1 |
| 1988 | 2 |
| 1989 | 2 |
| 1990 | 1 |
| 1993 | 1 |
| 1994 | 4 |
| 1995 | 2 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 3 |
| 1999 | 2 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001632 | OPTI-CHECK PLUS MULTI-ANALYTE CONTROL, MODEL HC7009 | JJY | Substantially Equivalent | |
| K000103 | AVL OPTI R ANALYZER | CHL | Substantially Equivalent | |
| K993837 | AVL OPTI CRITICAL CARE ANALYZER | CGA | Substantially Equivalent | |
| K990092 | AVL OMNI MODULAR ANALYZER | CHL | Substantially Equivalent | |
| K984299 | AVL OPTI CRITICAL CARE ANALYZER | JFP | Substantially Equivalent | |
| K974784 | AVL OPTI CRITICAL CARE ANALYZER | CEM | Substantially Equivalent | |
| K974822 | AVL OPTI-CHECK PH/ BLOOD GAS/ ELECTROLYTE/THB/ SO2 CONTROL | JJY | Substantially Equivalent | |
| K972733 | AVL OMNI ANALYZER | CGA | Substantially Equivalent | |
| K972673 | AVL 9181 ELECTROLYTE ANALYZER | JFP | Substantially Equivalent | |
| K963964 | AVL COMPACT 3 PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K961458 | AVL 9180 ELECTROLYTE ANALYZER | JFP | Substantially Equivalent | |
| K961161 | AVL OPTI 1 PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K954018 | AVL OMNI ANALYZER | GKR | Substantially Equivalent | |
| K945915 | AVL OMNI ANALYZER | JJC | Substantially Equivalent | |
| K944089 | AVL OPTI PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K943702 | AVL 988-4 ELECTROLYTE ANALYZER | JFP | Substantially Equivalent | |
| K943570 | AVL COMPACT 1 PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K942616 | AVL COMPACT 2 PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K932642 | AVL 9110PH ANALYZER | CHL | Substantially Equivalent | |
| K895317 | AVL MODEL 995HB PH/BLOOD GAS ANALYZER | CHL | Substantially Equivalent | |
| K895466 | AVL MODEL 912 CO-OXYLITE | GLY | Substantially Equivalent | |
| K891578 | AVL MODEL 987 ELECTROLYTE ANALYZER | CHL | Substantially Equivalent | |
| K882154 | HEPAX (TENS) | GZJ | Substantially Equivalent | |
| K883240 | AVL MODEL 986 ELECTROLYTE ANALYZER | CEM | Substantially Equivalent | |
| K870657 | AVL MODEL 985 ELECTROLYTE ANALYZER | CEM | Substantially Equivalent | |
| K863333 | AVL ISE-TROL ELECTROLYTE CONTROL | JJR | Substantially Equivalent | |
| K862819 | AVL MODEL 984 ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K861087 | AVL MODEL 983 ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K844587 | AVL MODEL 982 ELECTROLYTE ANALYZER | JGS | Substantially Equivalent | |
| K834601 | AVL MODEL 945 BLOOD GAS SYSTEM | CHL | Substantially Equivalent | |
| K831379 | MODEL 947 VIDEO BLOOD GAS SYS | CHL | Substantially Equivalent | |
| K831395 | AVL 0073 MICROSAMPLER | FMI | Substantially Equivalent | |
| K821885 | REF. ELECTRODE SOL'N.;STANDARD B | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JJCAnalyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
- JIXCalibrator, Multi-Analyte Mixture
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFPElectrode, Ion Specific, Calcium
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- JJRElectrolyte Controls (Assayed And Unassayed)
- CGAGlucose Oxidase, Glucose
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- FMINeedle, Hypodermic, Single Lumen
- GLYOximeter To Measure Hemoglobin
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- GKRSystem, Hemoglobin, Automated
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