DRYSPOT E.COLI 0157 KIT
FDA 510(k) clearance K993401 · decided 2000-02-28
Clearance details
- K-number
- K993401
- Device name
- DRYSPOT E.COLI 0157 KIT
- Applicant
- Oxoid , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-08
- Decision date
- 2000-02-28
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- GNA
- Device class
- 1
- Regulation number
- 866.3255
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Basingstoke, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Oxoid
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 |
|---|---|---|
| MODIFICATION TO BIOSTAR OIA SHIGATOX (K071799) | Iverness Medical Professional Diagnostics | 2007-10-02 |
| DUOPATH VEROTOXINS GLISA TEST (K031367) | Emd Chemicals, Inc. | 2004-01-23 |
| VTEC-RPLA SEIKEN (K981734) | Denka Seiken'S | 1998-09-22 |
| WELLCOLEX E-COLI OI57 ZC60 (K962028) | Murex Diagnostics, Inc. | 1996-11-01 |
| PREMIER EHEC (K953362) | Meridian Diagnostics, Inc. | 1995-11-14 |
| PREMIER EHEC (K950167) | Meridian Diagnostics, Inc. | 1995-04-14 |
| RIM E.COLI 0157:H7 LATEX TEST (K933457) | Remel Co. | 1994-04-20 |
| E. COLI 0157 LATEX TEST (K903714) | Pro-Lab, Inc. | 1991-01-24 |
| ESCHERICHIA COLI 0157 LATEX AGGLUTINATION TEST KIT (K884026) | Oxoid U.S.A., Inc. | 1989-02-03 |
| PHADEBACT ETEC-LT TEST (K874288) | Pharmacia, Inc. | 1988-09-02 |
| DIAGNOSTIC REAGENT VET-RPLA (K855234) | Oxoid U.S.A., Inc. | 1986-11-04 |
Recalls involving this device
No recalls on record reference this clearance.