Remel Co.
Mchenry, IL, US
Remel Co. appears in FDA device records in Mchenry, IL. FDA records list 51 510(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
- 51
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 51FDA records hold 51 510(k) clearances for Remel Co. between 1979 and 1984. The busiest year on record is 1984, with 20. The most recent is 1984, with 20.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1979 | 2 |
| 1980 | 13 |
| 1981 | 7 |
| 1983 | 9 |
| 1984 | 20 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K843194 | V AGAR SELECTIVE DEEPS | JSI | Substantially Equivalent | |
| K843193 | STREP SELECTIVE II | JSI | Substantially Equivalent | |
| K842297 | ARGINIE BROTH | JSF | Substantially Equivalent | |
| K840685 | PORPHYRIN TEST AGAR | JSF | Substantially Equivalent | |
| K840338 | HAEMOPHILUS I.D. II TRIPLATE | JSI | Substantially Equivalent | |
| K840708 | COLISTIN DISC | JTO | Substantially Equivalent | |
| K840614 | RIFAMPIN DISC | JTO | Substantially Equivalent | |
| K840553 | HEMASTAPH | JTL | Substantially Equivalent | |
| K840981 | NIACIN REAGENT STRIP | MJD | Substantially Equivalent | |
| K840890 | BUFFERED CYE AGAR DEEP W/SUPPLEMENTS | JSJ | Substantially Equivalent | |
| K840889 | CLOSTRIDIUM DIFFICILE AGAR DEEP & | JSI | Substantially Equivalent | |
| K840819 | MICRODASE | JTO | Substantially Equivalent | |
| K840615 | YERSINIA SUPPLEMENT | JSI | Substantially Equivalent | |
| K840483 | NOVOBIOCIN DISC | JTO | Substantially Equivalent | |
| K840554 | BLOOD AGAR W/AMPICILLIN | JSJ | Substantially Equivalent | |
| K840190 | MACCONKEY AGAR W/TWEEN 80 & AMPICIL | JSI | Substantially Equivalent | |
| K833967 | CVA | JSJ | Substantially Equivalent | |
| K834066 | TINSDALE ENRICHMENT | JSK | Substantially Equivalent | |
| K834068 | CEB | JSJ | Substantially Equivalent | |
| K834067 | LEGIONELLA DIFFERENTIATION DISK | GRO | Substantially Equivalent | |
| K834029 | BIO-UREA | JTO | Substantially Equivalent | |
| K834028 | BIO-ORNITHINE | JTO | Substantially Equivalent | |
| K834022 | PVP IODINE | JTO | Substantially Equivalent | |
| K833968 | 10B | JSN | Substantially Equivalent | |
| K833963 | HAEMOPHILUS IDENTIFICATION TEST KIT | JTO | Substantially Equivalent | |
| K834065 | A3B | JSN | Substantially Equivalent | |
| K830322 | C.A.T. REAGENT KIT | JTQ | Substantially Equivalent | |
| K830396 | UREA-PDA DISK | JSS | Substantially Equivalent | |
| K830323 | LYSOSTAPHIN REAGENT SET | JTO | Substantially Equivalent | |
| K812698 | GC DISK | JTR | Substantially Equivalent | |
| K812084 | SPS DISK | JTO | Substantially Equivalent | |
| K812083 | BILE DISK | JTO | Substantially Equivalent | |
| K812082 | KANAMYCIN DISK | JTO | Substantially Equivalent | |
| K810541 | BETA LYSIN DISK | JTO | Substantially Equivalent | |
| K803304 | ACRIDINE ORANGE STAIN | IDC | Substantially Equivalent | |
| K802757 | BUFFERED CHARCOAL YEAST EXTRACT AGAR | JSJ | Substantially Equivalent | |
| K802758 | SELECTIVE CHARCOAL YEAST EXTRACT AGAR | JSJ | Substantially Equivalent | |
| K803054 | SAF FIXATIVE | IGB | Substantially Equivalent | |
| K802571 | CYE BIPHASIC BLOOD CULTURE MEDIUM | JSJ | Substantially Equivalent | |
| K802415 | BHI AGAR/BHI BROTH BIPHASIC BLOOD CLT.BT | JSG | Substantially Equivalent | |
| K801493 | ALA SWAB | JTO | Substantially Equivalent | |
| K801492 | PORPHYRIN (ALA) DISK | JTO | Substantially Equivalent | |
| K801305 | HIPPURATE DISK | JTC | Substantially Equivalent | |
| K800803 | NITRATE SWAB-RAPID TEST | JXB | Substantially Equivalent | |
| K800734 | RAPID FERMENTATION AGAR (RFA) | JSE | Substantially Equivalent | |
| K800745 | CELLIBIOSE-ARGININE-LYSINE AGAR (CAL) | JSI | Substantially Equivalent | |
| K800287 | CEPH LACTAM DISK | JSF | Substantially Equivalent | |
| K792675 | CHARCOAL YEAST EXTRACT(CYE) AGAR | JSJ | Substantially Equivalent | |
| K792676 | CAMPY THIO | JSJ | Substantially Equivalent | |
| K792235 | COAGULASE PLASMA | JTL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- IDCAcridine Orange
- GROAntisera, Fluorescent, All Types, Hemophilus Spp.
- JTQBath, Incubators/Water, All
- MJDCulture Media, Antimycobacteria, Susceptibility Test
- JSECulture Media, Multiple Biochemical Test
- JSGCulture Media, Non-Selective And Non-Differential
- JSNCulture Media, Propagating Transport
- JSICulture Media, Selective And Differential
- JSJCulture Media, Selective And Non-Differential
- JSFCulture Media, Single Biochemical Test
- JTCDevice, Microtiter Diluting/Dispensing
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- JSSKit, Identification, Enterobacteriaceae
- JXBKit, Identification, Yeast
- JTRKit, Quality Control For Culture Media
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- IGBSolution, Formalin-Sodium Acetate
- JSKSupplement, Culture Media
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