510(k) K854490
- Device
- IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES
- Applicant
- AMERICAN MICRO SCAN
- 510(k) number
- K854490
- Product code
- GRP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-12-27
- Date received
- 1985-11-12
- Regulation
- 866.3300
- Classification name
- Antisera, All Types, H. Influenza
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- KRISTA UNDERWOOD
- Address
- 855 57th. St. Suite G Sacramento CA US 95819 95819
FDA Registration Numbers#
- 9614373
- 8020667
- 1119779
- 3003750284
- 3012471076
- 1025402
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K884967 | BACTIGEN(R) H. INFLUENZAE TYPE B | Armkel, LLC | 1989-02-07 |
| K831525 | H-FLU B ELISA TEST | Seragen Diagnostics, Inc. | 1983-09-29 |
| K823348 | H. INFLUENZA B ANTISERA FOR CIE | Diagnostica, Inc. | 1982-12-28 |
| K821266 | BBL DIRECTIGEN MENINGITIS TEST KIT | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 |
| K820192 | HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
Legacy Summary#
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FDA Review#
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