ANTIBODY TO MUMPS VIRUS IFA TEST
FDA 510(k) clearance K822826 · decided 1982-12-03
Clearance details
- K-number
- K822826
- Device name
- ANTIBODY TO MUMPS VIRUS IFA TEST
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-21
- Decision date
- 1982-12-03
- Days to decision
- 73 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 |
| VIRAL ANTISERA, FLUORESCEIN LABELED (K770216) | Flow Laboratories, Inc. | 1977-03-01 |
Recalls involving this device
No recalls on record reference this clearance.