Haemophilus Influenzae Type B Antiserum
FDA 510(k) K820192 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK820192
Submission
- Device name
- Haemophilus Influenzae Type B Antiserum
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Walker, MI, US - Received
- January 25, 1982
- Decision date
- March 11, 1982
- 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 |
| 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 |
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| K810077 | Omega Therapeutic Drug Monit. Control S.DIF · Traditional | 01/28/1981SE |
| K802610 | Alert A,Hdl-Apoliporotein a, Test KitDER · Traditional | 01/05/1981SE |
| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
| K790249 | Test CellsKSF · Traditional | 05/16/1979SE |
| K781225 | Globulin Test, Human Thyroxine BindingCEE · Traditional | 08/31/1978SE |
| K780962 | Automated EnzymeKSK · Traditional | 07/27/1978SE |
| K780785 | Dilutor TransporterJQW · Traditional | 06/14/1978SE |
Questions and answers
When was Haemophilus Influenzae Type B Antiserum cleared by the FDA?
Haemophilus Influenzae Type B Antiserum (K820192) received a 510(k) decision of Substantially Equivalent on March 11, 1982, 45 days after the submission was received.
What is the product code of K820192?
The FDA product code is GRP – Antisera, All Types, H. Influenza, a Class II (moderate risk) device regulated under 21 CFR 866.3300.