ADENOVIRUS GROUP-FA LABELLED PRESERUM
FDA 510(k) clearance K770811 · decided 1977-05-20
Clearance details
- K-number
- K770811
- Device name
- ADENOVIRUS GROUP-FA LABELLED PRESERUM
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-05-03
- Decision date
- 1977-05-20
- Days to decision
- 17 days
- Clearance type
- Traditional
- Product code
- GNY
- Device class
- 1
- Regulation number
- 866.3020
- 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 |
|---|---|---|
| RESP. PANEL 1 INDIRECT IMMUNOFLUORESCENCE ASSAY (K922801) | Light Diagnostics | 1993-01-06 |
| MURINE MONOCLONAL ANTI-ADENOVIRUS IGG (K885310) | Whittaker Bioproducts, Inc. | 1989-02-16 |
| ADENOVIRUS-GROUP FA LABELLED (8-651 RF) (K770807) | Flow Laboratories, Inc. | 1977-05-20 |
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 |