510(k) K955797
- Device
- IGM IMMUNOTRUBIDIMETRIC & CALIBRATOR
- Applicant
- RANDOX LABORATORIES, LTD.
- 510(k) number
- K955797
- Product code
- DFT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-05
- Date received
- 1995-12-22
- Regulation
- 866.5550
- Classification name
- Igm, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JULIE TAYLOR
- Address
- Ardmore, Diamond Rd. Crumlin IE BT29 4QY BT29 4QY
FDA Registration Numbers#
- 1618982
- 3005094123
- 3004493545
- 3002809144
- 3016438761
- 2050010
- 1181121
- 1000403749
- 2050012
- 3000148879
- 3005333358
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DFT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K983132 | IGM | Abbott Laboratories | 1998-11-04 |
| K962201 | QUANTEX IGM | Instrumentation Laboratory CO | 1996-09-25 |
| 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 |
Legacy Summary#
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FDA Review#
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