STAPHAUREX ZL30
FDA 510(k) clearance K851949 · decided 1985-05-22
Clearance details
- K-number
- K851949
- Device name
- STAPHAUREX ZL30
- Applicant
- Wellcome Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1985-05-03
- Decision date
- 1985-05-22
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- GTN
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Research Triangle Pk, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Wellcome 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.
| Record | Firm | Date |
|---|---|---|
| DIAGNOSTIC REAGENT SET-RPLA (K855233) | Oxoid U.S.A., Inc. | 1986-11-04 |
| DIAGNOSTIC REAGENT TST-RPLA (K855236) | Oxoid U.S.A., Inc. | 1986-11-04 |
| AGGLUTINOTEST-STAPHYLOLISIN (K791453) | Volu Sol Medical Industries | 1979-09-24 |
Recalls involving this device
No recalls on record reference this clearance.