Indirect Enzyme Linked Immunosorbent Assay Igg Ant
FDA 510(k) K853484 · Biotech Research Laboratories, Inc.
510(k) numberK853484
Submission
- Device name
- Indirect Enzyme Linked Immunosorbent Assay Igg Ant
- Applicant
- Biotech Research Laboratories, Inc.
Rockville, MD, US - Received
- August 20, 1985
- Decision date
- February 5, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GNP – Antiserum, Cf, Epstein-Barr Virus
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.3235
- Specialty
- Microbiology
Other 510(k)s with product code GNP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020717 | Ebv V Vca Igm Elisa Kit Model# EBM-200GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020707 | Ebv-Ebna Igg Elisa Kit, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K020706 | Ebv-Vca Igg Elisa Test, Model EBG-100GNP · Traditional | Pan Bio Pty. , Ltd. | 06/13/2002SE |
| K981831 | Is Ebv-Ea-D Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K981829 | Is EBV-EBNA-1 Igg Elisa Test SystemGNP · Traditional | Diamedix Corp. | 02/16/1999SE |
| K901156 | Eia for Igg Antibody to Ebv Vca in Human SerumGNP · Traditional | Granbio, Inc. | 09/12/1990SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | Electro-Nucleonics, Inc. | 04/28/1989SE |
| K884591 | Ebv-Vca Antibody (Igg)GNP · Traditional | Hillcrest Biologicals | 01/24/1989SE |
| K880885 | Ebv-Vca Igg Antibody Test System (Enzyme)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
| K880883 | Ebv-Vca Igg Antibody Test System (Fluorescent)GNP · Traditional | Immuno Concepts, Inc. | 08/30/1988SE |
More from Immuno Concepts, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K821849 | Ebv-Vca Antibody Assay KitJRY · Traditional | 08/12/1982SE |
Questions and answers
When was Indirect Enzyme Linked Immunosorbent Assay Igg Ant cleared by the FDA?
Indirect Enzyme Linked Immunosorbent Assay Igg Ant (K853484) received a 510(k) decision of Substantially Equivalent on February 5, 1986, 169 days after the submission was received.
What is the product code of K853484?
The FDA product code is GNP – Antiserum, Cf, Epstein-Barr Virus, a Class I (low risk) device regulated under 21 CFR 866.3235.