American Micro Scan
Mchenry, IL, US
American Micro Scan appears in FDA device records in Mchenry, IL. FDA records list 24 510(k) clearances between and , 12 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
- 24
- PMA records
- 12
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for American Micro Scan between 1983 and 1987. The busiest year on record is 1986, with 9. The most recent is 1987, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 5 |
| 1984 | 3 |
| 1985 | 3 |
| 1986 | 9 |
| 1987 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K870029 | IMMUNOSCAN(TM) DIRECT STREPTOCOCCUS PNEUMONIAE | GWC | Substantially Equivalent | |
| K864662 | CHLAMYDIAE FLUOR. AB TEST FOR DETECTION IN SMEARS | LJP | Substantially Equivalent | |
| K863776 | MICRODILUTION MIC PANELS | JWY | Substantially Equivalent | |
| K864674 | MICRODILUTION IDENTIFICATION PANELS | JSE | Substantially Equivalent | |
| K864389 | CHLAMYDIAE FLOURESCENT MONOCLONAL ANTIBODY TEST | LJP | Substantially Equivalent | |
| K863038 | GRAM POSITIVE FLUORESCENT IDENTIFICATION PANEL | LQL | Substantially Equivalent | |
| K862642 | GRAM NEGATIVE FLUORESCENT IDENTIFICATION PANEL | LQM | Substantially Equivalent | |
| K862332 | ANAEROBE RAPID CHROMOGENIC ID PANEL | JSP | Substantially Equivalent | |
| K862140 | MICRODILUTION PANELS | JWY | Substantially Equivalent | |
| K861584 | GRAM NEGATIVE COMBO PANEL TYPE 3 | JWY | Substantially Equivalent | |
| K860575 | YEAST IDENTIFICATION PANEL | JXB | Substantially Equivalent | |
| K854278 | NEG COMBO BREAKPOINT PANEL POS COMBO | JWX | Substantially Equivalent | |
| K854447 | IMMUNOSCAN RAPID DIRECT GROUP A STREP TEST | GTZ | Substantially Equivalent | |
| K854490 | IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES | GRP | Substantially Equivalent | |
| K852976 | NEG COMBO PANELS, NEG/URI MIC,NEG ID,POS MIC | Substantially Equivalent | ||
| K854448 | AUTOSCAN W/A SYSTEM | JTO | Substantially Equivalent | |
| K844086 | POS COMBO PANEL | JTO | Substantially Equivalent | |
| K842947 | MICROBIOLOGICAL TRAY READER-MANUAL | JJQ | Substantially Equivalent | |
| K842874 | RADIOMETRIC BLOOD CULTURE VIALS, AEROBE | JTA | Substantially Equivalent | |
| K833027 | HAEMOPHILUS/NEISSERIA IDENTIF-PANEL | Substantially Equivalent | ||
| K831061 | PVA FIXATIVE/FORMALIN | LDZ | Substantially Equivalent | |
| K831060 | TRICHROME STAIN | JTS | Substantially Equivalent | |
| K831058 | SAF FIXATIVE | LDW | Substantially Equivalent | |
| K831059 | P & T MEDIUM | JSM | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GTZAntisera, All Groups, Streptococcus Spp.
- GRPAntisera, All Types, H. Influenza
- GWCAntisera, All Types, Streptococcus Pneumoniae
- LJPAntiserum, Fluorescent, Chlamydia Trachomatis
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- JSECulture Media, Multiple Biochemical Test
- JSMCulture Media, Non-Propagating Transport
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- LDWFixative, Acid Containing
- LDZFixative, Alcohol Containing
- LQMGram Negative Identification Panel
- LQLGram Positive Identification Panel
- JSPKit, Anaerobic Identification
- JXBKit, Identification, Yeast
- JWXKit, Screening, Staphylococcus Aureus
- JWYManual Antimicrobial Susceptibility Test Systems
- JTAMonitor, Microbial Growth
- LTTPanels, Test, Susceptibility, Antimicrobial
- JTSStains, Microbiologic
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