ENTEROTUBE II
FDA 510(k) clearance K781236 · decided 1978-08-31
Clearance details
- K-number
- K781236
- Device name
- ENTEROTUBE II
- Applicant
- Hoffmann-La Roche, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1978-07-20
- Decision date
- 1978-08-31
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- JSS
- Device class
- 1
- Regulation number
- 866.2660
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Nutley, NJ, US
- Third-party review
- No
- Expedited review
- No
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| E. COLI PNA FISH (K082068) | Advandx, Inc. | 2009-06-25 |
| EK/P. AERUGINOSA PNA FISH (K081433) | Advandx, Inc. | 2009-03-26 |
| E.COLI/P. AERUGINOSA PNA FISH (K081309) | Advandx, Inc. | 2008-12-19 |
| ALAMAR BACTERIAL IDENTIFICATION TEST PANEL (K926002) | Alamar Biosciences Laboratory, Inc. | 1993-09-23 |
| API 20E/UNISCEPT 20E (K924814) | Analytical Products, Inc. | 1993-03-11 |
| CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM (K926017) | Becton Dickinson Microbiology Systems | 1993-03-11 |
| CRYSTAL ENTERIC/NONFERMENTER ID SYSTEM (K926018) | Becton Dickinson Microbiology Systems | 1993-03-11 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| CEA-ROCHE TEST KIT (P800063/S004) | Hoffmann-La Roche, Inc. | 1983-10-18 |
| CEA-ROCHE TEST KIT (P800063/S003) | Hoffmann-La Roche, Inc. | 1982-10-21 |
| CEA-ROCHE TEST KIT (P800063/S002) | Hoffmann-La Roche, Inc. | 1982-09-16 |
| CEA-ROCHE TEST KIT (P800063/S001) | Hoffmann-La Roche, Inc. | 1982-03-03 |