DFT — Igm, Antigen, Antiserum, Control Class II
FDA product code DFT covers "Igm, Antigen, Antiserum, Control", a Class II medical device regulated under 21 CFR 866.5550. Submissions are reviewed by the Immunology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- DFT
- Device Class
- Class II
- Regulation Number
- 866.5550
- Submission Type
- Review Panel
- IM
- Medical Specialty
- Immunology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K983132 | abbott laboratories | IGM | November 4, 1998 |
| K962201 | instrumentation laboratory | QUANTEX IGM | September 25, 1996 |
| K955797 | randox laboratories | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | April 5, 1996 |
| K945522 | beckman-diagnostic systems group | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | December 12, 1994 |
| K901453 | isolab | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | April 12, 1990 |
| K894417 | reagents applications | RAICHEM(TM) SPIA(TM) IGM REAGENTS | August 2, 1989 |
| K884147 | orion diagnostica | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | October 27, 1988 |
| K880828 | wako chemicals usa | WAKO(TM) IGM-HA DIRECT | March 25, 1988 |
| K873871 | unipath | IMMUNOGLOBULINS M | October 13, 1987 |
| K872237 | kallestad diag, a div. of erbamont | KALLESTAD QM300 IGM ANTIBODY PACK | July 9, 1987 |
| K871498 | helena laboratories | TITAN GEL IMMUNOFIX CONTROLS | April 29, 1987 |
| K862762 | boehringer mannheim | TINA-QUANT(R) IGM | September 8, 1986 |
| K855010 | kallestad laboratories | QUANTIMETRIC PLUS IGM REAGENT KIT | February 28, 1986 |
| K853469 | gilford | GILFORD IMMUNOGLOBULIN M REAGENT | September 16, 1985 |
| K842327 | bartels immunodiagnostic supplies | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | August 2, 1984 |
| K841814 | miles laboratories | OPTIMATE IGM TEST | June 22, 1984 |
| K832265 | gelco diagnostics | FITC GOAT ANTI-HUMAN IGM H CHAIN | October 31, 1983 |
| K832259 | gelco diagnostics | GOAT ANTI-HUMAN IGM H CHAIN | October 28, 1983 |
| K831608 | intl. diagnostic technology | FIAX IGM TEST KIT | June 22, 1983 |
| K831103 | worthington diagnostic systems | TIA-IGM REAGENT & CALIBRATOR SETS | April 27, 1983 |