Bactigen(R) H. Influenzae Type B
FDA 510(k) K884967 · Armkel, LLC
510(k) numberK884967
Submission
- Device name
- Bactigen(R) H. Influenzae Type B
- Applicant
- Armkel, LLC
Cranbury, NJ, US - Received
- November 30, 1988
- Decision date
- February 7, 1989
- 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
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|---|---|---|---|
| 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 |
| K820192 | Haemophilus Influenzae Type B AntiserumGRP · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 03/11/1982SE |
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Questions and answers
When was Bactigen(R) H. Influenzae Type B cleared by the FDA?
Bactigen(R) H. Influenzae Type B (K884967) received a 510(k) decision of Substantially Equivalent on February 7, 1989, 69 days after the submission was received.
What is the product code of K884967?
The FDA product code is GRP – Antisera, All Types, H. Influenza, a Class II (moderate risk) device regulated under 21 CFR 866.3300.