ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
FDA 510(k) clearance K821249 · decided 1982-07-30
Clearance details
- K-number
- K821249
- Device name
- ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS
- Applicant
- Electro-Nucleonics Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-04-30
- Decision date
- 1982-07-30
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- GRE
- Device class
- 1
- Regulation number
- 866.3520
- 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 |
|---|---|---|
| RUBEOLA TEST (K884004) | Gull Laboratories, Inc. | 1988-12-05 |
| FIAX TEST KIT FOR MEASLES-G ANTIBODIES FLYORESCENT (K853067) | Idt, A Division of Whittaker M.A. Bioproducts | 1985-10-22 |
| MEASLESVIRUS FLOURE. CONJUGATED ANTISERU (K770687) | Microbiological Assoc. | 1977-06-14 |
Recalls involving this device
No recalls on record reference this clearance.