FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
FDA 510(k) clearance K874607 · decided 1988-01-27
Clearance details
- K-number
- K874607
- Device name
- FOUR LITER BAG FOR USE W/REDY 2000/DIALERT SYSTEMS
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-11-09
- Decision date
- 1988-01-27
- Days to decision
- 79 days
- Clearance type
- Traditional
- Product code
- LKN
- Device class
- U
- Medical specialty
- Unknown
- Advisory committee
- Unknown
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Organon Teknika Corp.
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.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001) | Organon Teknika Corp. | 1990-03-21 |
| HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001) | Organon Teknika Corp. | 1990-03-21 |
| 9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001) | Organon Teknika Corp. | 1990-03-21 |
| AUTOBAC MIC TEST SYSTEM (N50524/S033) | Organon Teknika Corp. | 1990-01-22 |
| AUTOBAC MIC TEST SYSTEM (N50524/S035) | Organon Teknika Corp. | 1989-12-07 |
| AUTOBAC MIC TEST SYSTEM (N50524/S032) | Organon Teknika Corp. | 1989-06-13 |
| HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018) | Organon Teknika Corp. | 1989-02-06 |
| AUTOBAC MIC TEST SYSTEM (N50524/S031) | Organon Teknika Corp. | 1988-12-28 |