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