H. INFLUENZA B ANTISERA FOR CIE
FDA 510(k) clearance K823348 · decided 1982-12-28
Clearance details
- K-number
- K823348
- Device name
- H. INFLUENZA B ANTISERA FOR CIE
- Applicant
- Diagnostica, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-11-09
- Decision date
- 1982-12-28
- Days to decision
- 49 days
- Clearance type
- Traditional
- Product code
- GRP
- Device class
- 2
- Regulation number
- 866.3300
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| BACTIGEN(R) H. INFLUENZAE TYPE B (K884967) | Armkel, LLC | 1989-02-07 |
| IMMUNOSCAN DIRECT HEMOPHILUS INFLUENZAE TYPE B TES (K854490) | American Micro Scan | 1985-12-27 |
| H-FLU B ELISA TEST (K831525) | Seragen Diagnostics, Inc. | 1983-09-29 |
| BBL DIRECTIGEN MENINGITIS TEST KIT (K821266) | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1982-06-01 |
| HAEMOPHILUS INFLUENZAE TYPE B ANTISERUM (K820192) | Hyland Therapeutic Div., Travenol Laboratories | 1982-03-11 |
Recalls involving this device
No recalls on record reference this clearance.