Goat Anti-Human Igm H Chain
FDA 510(k) K832259 · Gelco Diagnostics, Inc.
510(k) numberK832259
Submission
- Device name
- Goat Anti-Human Igm H Chain
- Applicant
- Gelco Diagnostics, Inc.
Mchenry, IL, US - Received
- June 30, 1983
- Decision date
- October 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DFT – Igm, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
Other 510(k)s with product code DFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K983132 | IgmDFT · Traditional | Abbott Laboratories | 11/04/1998SE |
| K962201 | Quantex IgmDFT · Traditional | Instrumentation Laboratory CO | 09/25/1996SE |
| K955797 | Igm Immunotrubidimetric & CalibratorDFT · Traditional | Randox Laboratories, Ltd. | 04/05/1996SE |
| K945522 | I.D.-Zone Immunofixation Electrophoresis ControlsDFT · Traditional | Beckman-Diagnostic Systems Group | 12/12/1994SE |
| K901453 | Quik-Sep(R) Igm Rprotein G Affinity MethodDFT · Traditional | Isolab, Inc. | 04/12/1990SE |
| K894417 | Raichem(Tm) Spia(Tm) Igm ReagentsDFT · Traditional | Reagents Applications, Inc. | 08/02/1989SE |
| K884147 | Immunochemical Determination of Immunoglobulin MDFT · Traditional | Orion Diagnostica, Inc. | 10/27/1988SE |
| K880828 | Wako(Tm) Igm-Ha DirectDFT · Traditional | Wako Chemicals USA, Inc. | 03/25/1988SE |
| K873871 | Immunoglobulins MDFT · Traditional | Unipath , Ltd. | 10/13/1987SE |
| K872237 | Kallestad QM300 Igm Antibody PackDFT · Traditional | Kallestad Diag, A Div. of Erbamont, Inc. | 07/09/1987SE |
More from Kallestad Diag, A Div. of Erbamont, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K832270 | Goat Anti-Human LambaDEH · Traditional | 10/31/1983SE |
| K832267 | Fitc Goat Anti-Human LambaDES · Traditional | 10/31/1983SE |
| K832266 | Fitc Goat Anti-Human Kappa AffinityDFH · Traditional | 10/31/1983SE |
| K832265 | Fitc Goat Anti-Human Igm H ChainDFT · Traditional | 10/31/1983SE |
| K832263 | Fitc Goat Anti-Human Iga a ChainCZP · Traditional | 10/31/1983SE |
| K832262 | Fitc Goat Anti-Human ImmunoglobulinsCZN · Traditional | 10/31/1983SE |
| K832260 | Goat Anti-Human Kappa AffinityDEO · Traditional | 10/31/1983SE |
| K832258 | Goat Anti-Human Igg Y Chain SpecificDEW · Traditional | 10/31/1983SE |
| K832256 | Goat Anti-Human Immunoglobulins-DFH · Traditional | 10/31/1983SE |
| K832264 | Fitc Goat Anti-Human Igg Y ChainDEW · Traditional | 10/28/1983SE |
Questions and answers
When was Goat Anti-Human Igm H Chain cleared by the FDA?
Goat Anti-Human Igm H Chain (K832259) received a 510(k) decision of Substantially Equivalent on October 28, 1983, 120 days after the submission was received.
What is the product code of K832259?
The FDA product code is DFT – Igm, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.