STAPHYTECT-OD
FDA 510(k) clearance K940557 · decided 1994-07-28
Clearance details
- K-number
- K940557
- Device name
- STAPHYTECT-OD
- Applicant
- Unipath , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-07
- Decision date
- 1994-07-28
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- LHJ
- Device class
- 1
- Regulation number
- 866.3700
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Bedford Mk41 Oqg, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Unipath
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 |
|---|---|---|
| IMMUSTAPH LATEX AGGLUTINATION KIT (K842709) | Immucell Corp. | 1984-08-03 |
| STAPHYLOCOCCAL PROTEIN A INSOLUBLE (K812181) | Oxoid U.S.A., Inc. | 1981-08-25 |
Recalls involving this device
No recalls on record reference this clearance.