H-Flu B Elisa Test
FDA 510(k) K831525 · Seragen Diagnostics, Inc.
510(k) numberK831525
Submission
- Device name
- H-Flu B Elisa Test
- Applicant
- Seragen Diagnostics, Inc.
Mchenry, IL, US - Received
- May 12, 1983
- Decision date
- September 29, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GRP – Antisera, All Types, H. Influenza
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3300
- Specialty
- Microbiology
Other 510(k)s with product code GRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884967 | Bactigen(R) H. Influenzae Type BGRP · Traditional | Armkel, LLC | 02/07/1989SE |
| K854490 | Immunoscan Direct Hemophilus Influenzae Type B TesGRP · Traditional | American Micro Scan | 12/27/1985SE |
| K823348 | H. Influenza B Antisera for CieGRP · Traditional | Diagnostica, Inc. | 12/28/1982SE |
| K821266 | BBL Directigen Meningitis Test KitGRP · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 06/01/1982SE |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 03/11/1982SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K872148 | Vivid Chlamydia(Tm)LJC · Traditional | 08/19/1987SE |
| K851663 | Quick-Count Hematology ControlsJPK · Traditional | 07/23/1985SE |
| K852260 | Quick-Chem Calibration SetJIW · Traditional | 07/22/1985SE |
| K851520 | Ck/Ld Isoenzymes Controls(Human)JJT · Traditional | 06/25/1985SE |
| K851521 | LD-1(IMMUNO) Separation SetCEX · Traditional | 05/10/1985SE |
| K850209 | Quick-LyteJGS · Traditional | 02/27/1985SE |
| K844743 | Seratest Ena(Rnp/Sm) DeterminationLLL · Traditional | 02/04/1985SE |
| K842563 | Seratest DNA DeterminationLKJ · Traditional | 10/25/1984SE |
| K841504 | Quick-Count Plus 2GKL · Traditional | 06/11/1984SE |
| K840793 | Ck/Mb Immuno-Isoenzyme Control SerumJJT · Traditional | 04/13/1984SE |
Questions and answers
When was H-Flu B Elisa Test cleared by the FDA?
H-Flu B Elisa Test (K831525) received a 510(k) decision of Substantially Equivalent on September 29, 1983, 140 days after the submission was received.
What is the product code of K831525?
The FDA product code is GRP – Antisera, All Types, H. Influenza, a Class II (moderate risk) device regulated under 21 CFR 866.3300.