POSID SAMPLER
FDA 510(k) clearance K860508 · decided 1986-05-02
Clearance details
- K-number
- K860508
- Device name
- POSID SAMPLER
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-11
- Decision date
- 1986-05-02
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- JQW
- Device class
- 1
- Regulation number
- 862.2750
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Oklahoma City, OK, US
- Third-party review
- No
- Expedited review
- No
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| BD VIPER INSTRUMENT (K023955) | Becton, Dickinson & CO | 2003-06-24 |
| QUATRO SP SAMPLE PROCESSING SYSTEMS (200-499, INCLUSIVE) (K973335) | Zenyx Scientific , Ltd. | 1998-04-30 |
| 2700 SAMPLE MANAGER (K980180) | Waters Corporation | 1998-02-12 |
| MASTERCAP AM 5.0/MASTERCAP RM 5.0 (K970420) | Pharmacia, Inc. | 1997-06-30 |
| MINI SAMPLER PROCESSOR (K970616) | Cavro Scientific Instruments, Inc. | 1997-04-21 |
| GIO. DE VITA E C. S.R.L.(GDV) AUTOMATIC WASHING SYSTEM (K962687) | Nichols Institute Diagnostics | 1997-03-28 |
| MINI SAMPLE PROCESSOR (K962859) | Cavro Scientific Instruments, Inc. | 1996-10-29 |
| MICROLAB 4000, MICROLAB 4200 (K961896) | Hamilton Co. | 1996-08-16 |
| IMPACT (K961694) | Matrix Technologies Corp. | 1996-06-21 |
| GENESIS (K953345) | Tecan U.S., Inc. | 1995-11-21 |
| MEDTEC AUTOBLOT 2000 (K951753) | Medtec, Inc. | 1995-10-17 |
| ROBOCAP (K952025) | Pharmacia, Inc. | 1995-07-26 |
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 |