INFLUENZA HI ANTISERUM
FDA 510(k) clearance K780274 · decided 1978-02-28
Clearance details
- K-number
- K780274
- Device name
- INFLUENZA HI ANTISERUM
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-02-17
- Decision date
- 1978-02-28
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- GNS
- Device class
- 1
- Regulation number
- 866.3330
- 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 |
|---|---|---|
| GOAT ANTIINFLUENZA ANTISERA AUSSR (K780696) | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| GOAT ANTI-INFLUENZA ANTISERA ATEXAS (K780697) | Northeast Biomedical Labs., Inc. | 1978-05-03 |
| INFLUENZA HI PRESERUM A/TEXAS (K780277) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HI PRESERUM (K780273) | Flow Laboratories, Inc. | 1978-02-28 |
| INFLUENZA HI ANTISERUM A/TEXAS (K780276) | Flow Laboratories, Inc. | 1978-02-28 |
| GOAT ANTI-INFLUENZA ANTISERA (K780004) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780006) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
| GOAT ANTI-INFLUENZA ANTISERA (K780005) | Northeast Biomedical Labs., Inc. | 1978-01-20 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| 3M BRAND MICROBIAL PROFILE SYSTEM (N50538/S001) | Flow Laboratories, Inc. | 1981-04-17 |
| FLOW MIC SYSTEM (N50538) | Flow Laboratories, Inc. | 1980-07-15 |