MULTIPLE AUTO ANTIBODY TEST
FDA 510(k) clearance K791996 · decided 1980-01-16
Clearance details
- K-number
- K791996
- Device name
- MULTIPLE AUTO ANTIBODY TEST
- Applicant
- Meda Stat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-10-03
- Decision date
- 1980-01-16
- Days to decision
- 105 days
- Clearance type
- Traditional
- Product code
- DBL
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Meda Stat Diagnostics
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.
Recalls involving this device
No recalls on record reference this clearance.