VIRAL ANTISERA, FLUORESCEIN LABELED
FDA 510(k) clearance K770216 · decided 1977-03-01
Clearance details
- K-number
- K770216
- Device name
- VIRAL ANTISERA, FLUORESCEIN LABELED
- Applicant
- Flow Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-02-02
- Decision date
- 1977-03-01
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- GRA
- Device class
- 1
- Regulation number
- 866.3380
- 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 |
|---|---|---|
| MUMPS VIRUS (K894624) | Bion Ent., Ltd. | 1989-10-16 |
| ANTIBODY TO MUMPS VIRUS IFA TEST (K822826) | Electro-Nucleonics Laboratories, Inc. | 1982-12-03 |
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 |