BACTOGEN-H. INFLUENZAE TYPE B
FDA 510(k) clearance K800493 · decided 1980-04-04
Clearance details
- K-number
- K800493
- Device name
- BACTOGEN-H. INFLUENZAE TYPE B
- Applicant
- Armkel, LLC
- Decision
- Substantially Equivalent
- Date received
- 1980-03-04
- Decision date
- 1980-04-04
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- GRO
- 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 |
|---|---|---|
| LEGIONELLA CULTURE CONFIRMATIN KIT (K851271) | Gen-Probe, Inc. | 1985-07-08 |
| LEGIONELLA DIFFERENTIATION DISK (K834067) | Remel Co. | 1984-01-03 |
| PHADEBACT HAEMOPHILUS TEST (K802423) | Pharmacia, Inc. | 1980-11-12 |
Recalls involving this device
No recalls on record reference this clearance.