MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
FDA 510(k) clearance K770687 · decided 1977-06-14
Clearance details
- K-number
- K770687
- Device name
- MEASLESVIRUS FLOURE. CONJUGATED ANTISERU
- Applicant
- Microbiological Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-13
- Decision date
- 1977-06-14
- Days to decision
- 62 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
+ Add to Predicate Builder ◉ Watch Microbiological Assoc.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| ENI ANTIBODY TO MEASLES(RUBEOLA) VIRUS (K821249) | Electro-Nucleonics Laboratories, Inc. | 1982-07-30 |
Recalls involving this device
No recalls on record reference this clearance.