I M, Inc.
Mchenry, IL, US
I M, Inc. appears in FDA device records in Mchenry, IL. FDA records list 26 510(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
- 26
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for I M, Inc. between 1976 and 1984. The busiest year on record is 1976, with 15. The most recent is 1984, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 15 |
| 1978 | 2 |
| 1979 | 1 |
| 1983 | 7 |
| 1984 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K833399 | SYRINGE | FMF | Substantially Equivalent | |
| K833435 | MULTI PURPOSE SYRINGE | FMF | Substantially Equivalent | |
| K831795 | FIRST AID KITS | KDD | Substantially Equivalent | |
| K831794 | SETS & TRAYS | Substantially Equivalent | ||
| K831796 | URINE BAG SYSTEM | KNX | Substantially Equivalent | |
| K831798 | DISPOSABLE SCALPELS | KDC | Substantially Equivalent | |
| K831797 | HEMOSTATS | HRQ | Substantially Equivalent | |
| K831799 | PLASTIC DISPOSABLE RAZOR | LDQ | Substantially Equivalent | |
| K782070 | REAGENT, COCCI LATEX | GMG | Substantially Equivalent | |
| K780526 | CRYPTOCOCCAL ANTIGEN LATEX AGG. SYSTEM | GMD | Substantially Equivalent | |
| K770527 | CANDIDA IMMUNODIFFUSION KIT | GMI | Substantially Equivalent | |
| K760839 | VASPAR, SEALANT FOR FERMENTATIONS | Substantially Equivalent | ||
| K760838 | LACTO-PHENOL COTTON BLUE MOUNTING FL. | LEB | Substantially Equivalent | |
| K760837 | POTASSIUM HYDROXIDE W/GLYCEROL MTG FL. | Substantially Equivalent | ||
| K760825 | FUNGAL IMMUNODIFFUSION KIT | Substantially Equivalent | ||
| K760836 | NEGATIVE CONTROL SERUM | Substantially Equivalent | ||
| K760835 | ANTI-ASPERGILLUS CONT. SER. (MYCELIAL) | KFG | Substantially Equivalent | |
| K760834 | ANTI-COCCIDIOIDES CONT. SER. (MYCELIAL) | GMH | Substantially Equivalent | |
| K760833 | ANTI-BLASTOMYCES CONTROL SERUM (YEAST) | KFH | Substantially Equivalent | |
| K760832 | ANTI-HISTOPLASMA CONTROL SERUM (YEAST) | GMK | Substantially Equivalent | |
| K760831 | ANTI-HISTOPLASMA CONTROL SERUM(MYCELIAL) | GMK | Substantially Equivalent | |
| K760830 | ASPERGILLUS MYCELIAL ANTIGEN | JWT | Substantially Equivalent | |
| K760829 | COCCIDIOIDES MYCELIAL ANTIGEN | GMG | Substantially Equivalent | |
| K760828 | BLASTOMYCES YEAST ANTIGEN | JJJ | Substantially Equivalent | |
| K760827 | HISTOPLASMA YEAST ANTIGEN | GMJ | Substantially Equivalent | |
| K760826 | HISTOPLASMA MYCELIAL ANTIGEN | GMJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GMIAntigen, Cf And / Or Id, Coccidioides Immitis
- JWTAntigen, Cf, Aspergillus Spp.
- GMGAntigen, Latex Agglutination, Coccidioides Immitis
- GMJAntigens, Histoplasma Capsulatum, All
- GMDAntisera, Latex Agglutination, Cryptococcus Neoformans
- KFGAntiserum, Positive Control, Aspergillus Spp.
- KFHAntiserum, Positive Control, Blastomyces Dermatitidis
- GMHAntiserum, Positive Control, Coccidioides Immitis
- GMKAntiserum, Positive Control, Histoplasma Capsulatum
- KNXCollector, Urine, (And Accessories) For Indwelling Catheter
- JJJCounter (Beta, Gamma) For Clinical Use
- HRQHemostat
- KDCInstrument, Surgical, Disposable
- KDDKit, Surgical Instrument, Disposable
- LEBMounting Media
- FMFSyringe, Piston
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