Product code DFT
- Device name
- Igm, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Device class
- 2
- Regulation number
- 866.5550
- Review panel
- IM
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983132 | IGM | Abbott Laboratories | 1998-11-04 |
| K962201 | QUANTEX IGM | Instrumentation Laboratory CO | 1996-09-25 |
| K955797 | IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR | Randox Laboratories, Ltd. | 1996-04-05 |
| K945522 | I.D.-ZONE IMMUNOFIXATION ELECTROPHORESIS CONTROLS | Beckman-Diagnostic Systems Group | 1994-12-12 |
| K901453 | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | Isolab, Inc. | 1990-04-12 |
| K894417 | RAICHEM(TM) SPIA(TM) IGM REAGENTS | Reagents Applications, Inc. | 1989-08-02 |
| K884147 | IMMUNOCHEMICAL DETERMINATION OF IMMUNOGLOBULIN M | Orion Diagnostica, Inc. | 1988-10-27 |
| K880828 | WAKO(TM) IGM-HA DIRECT | Wako Chemicals USA, Inc. | 1988-03-25 |
| K873871 | IMMUNOGLOBULINS M | Unipath , Ltd. | 1987-10-13 |
| K872237 | KALLESTAD QM300 IGM ANTIBODY PACK | Kallestad Diag, A Div. of Erbamont, Inc. | 1987-07-09 |
| K871498 | TITAN GEL IMMUNOFIX CONTROLS | Helena Laboratories | 1987-04-29 |
| K862762 | TINA-QUANT(R) IGM | Boehringer Mannheim Corp. | 1986-09-08 |
| K855010 | QUANTIMETRIC PLUS IGM REAGENT KIT | Kallestad Laboratories, Inc. | 1986-02-28 |
| K853469 | GILFORD IMMUNOGLOBULIN M REAGENT | Gilford | 1985-09-16 |
| K842327 | AMER. HISTO-ID SYS PRIMARY IGM S7920-31 | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-02 |
| K841814 | OPTIMATE IGM TEST | Miles Laboratories, Inc. | 1984-06-22 |
| K832265 | FITC GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | 1983-10-31 |
| K832259 | GOAT ANTI-HUMAN IGM H CHAIN | Gelco Diagnostics, Inc. | 1983-10-28 |
| K831608 | FIAX IGM TEST KIT | Intl. Diagnostic Technology | 1983-06-22 |
| K831103 | TIA-IGM REAGENT & CALIBRATOR SETS | Worthington Diagnostic Systems | 1983-04-27 |
| K830606 | QUIK-SEP IGM ISOLATION SYSTEM | Isolab, Inc. | 1983-03-24 |
| K812632 | ACA IMMUNOGLOBIN M TEST PACK | E.I. Dupont DE Nemours & Co., Inc. | 1981-09-29 |
| K811124 | AIM SYSTEM (FOR IGM) | Icl Scientific | 1981-05-08 |
| K803251 | AIP SYSTEM-METHOD FOR IGM | Icl Scientific | 1981-01-26 |
| K802177 | GOAT ANTI-HUMAN IGM | Protos Laboratories | 1980-10-31 |
| K801282 | J.T. BAKER IMMUNO. M. NEPHELOMETRIC ASSA | J.T. Baker Chemical Co. | 1980-06-30 |
| K800167 | IMMUNOGLOBULIN M REAGENT SYSTEM | Calbiochem-Behring Corp. | 1980-02-05 |
| K791402 | LANCER L-INA ANTI-IGM | Sherwood Medical Co. | 1979-10-17 |
| K772254 | IMMUNOGLOBULIN M NEPHEL. ASSAY | Kallestad Laboratories, Inc. | 1977-12-22 |
| K770963 | GOAT ANTISERUM IGM NEPHELOMHTRIC | Kallestad Laboratories, Inc. | 1977-06-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00380740169916 | Alinity | ABBOTT IRELAND | 2021-04-29 |
| 00380740169923 | ARCHITECT | ABBOTT IRELAND | 2021-04-02 |
| 00380740175115 | ARCHITECT | Abbott GmbH | 2020-11-06 |
| 03610230007365 | Yumizen C1200 Immunoglobulin M | HORIBA ABX SAS | 2020-07-13 |
| 00380740150693 | Alinity | Abbott GmbH | 2019-07-08 |
| 05055273204001 | IgM | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| 05055273204025 | IgM | RANDOX LABORATORIES LIMITED | 2016-09-24 |
| M52594000 | ImmunoFix Controls | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 00380740000202 | ARCHITECT | ABBOTT LABORATORIES | 2016-06-06 |