Immunoscan Direct Hemophilus Influenzae Type B Tes
FDA 510(k) K854490 · American Micro Scan
510(k) numberK854490
Submission
- Device name
- Immunoscan Direct Hemophilus Influenzae Type B Tes
- Applicant
- American Micro Scan
Sacramento, CA, US - Received
- November 12, 1985
- Decision date
- December 27, 1985
- 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 |
| K831525 | H-Flu B Elisa TestGRP · Traditional | Seragen Diagnostics, Inc. | 09/29/1983SE |
| 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 |
|---|---|---|
| K870029 | Immunoscan(Tm) Direct Streptococcus PneumoniaeGWC · Traditional | 03/25/1987SE |
| K864662 | Chlamydiae Fluor. AB Test for Detection in SmearsLJP · Traditional | 03/25/1987SE |
| K863776 | Microdilution Mic PanelsJWY · Traditional | 02/02/1987SE |
| K864674 | Microdilution Identification PanelsJSE · Traditional | 01/05/1987SE |
| K864389 | Chlamydiae Flourescent Monoclonal Antibody TestLJP · Traditional | 12/04/1986SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | 09/30/1986SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | 09/11/1986SE |
| K862332 | Anaerobe Rapid Chromogenic Id PanelJSP · Traditional | 08/27/1986SE |
| K862140 | Microdilution PanelsJWY · Traditional | 07/16/1986SE |
| K861584 | Gram Negative Combo Panel Type 3JWY · Traditional | 06/17/1986SE |
Questions and answers
When was Immunoscan Direct Hemophilus Influenzae Type B Tes cleared by the FDA?
Immunoscan Direct Hemophilus Influenzae Type B Tes (K854490) received a 510(k) decision of Substantially Equivalent on December 27, 1985, 45 days after the submission was received.
What is the product code of K854490?
The FDA product code is GRP – Antisera, All Types, H. Influenza, a Class II (moderate risk) device regulated under 21 CFR 866.3300.