WASHER 500 MICROELISA SYSTEM
FDA 510(k) clearance K884695 · decided 1988-12-13
Clearance details
- K-number
- K884695
- Device name
- WASHER 500 MICROELISA SYSTEM
- Applicant
- Organon Teknika Corp.
- Decision
- Substantially Equivalent
- Date received
- 1988-11-09
- Decision date
- 1988-12-13
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JTC
- Device class
- 1
- Regulation number
- 866.2500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Durham, NC, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FILTERMATE UNIVERSAL HARVESTER (K924907) | Packard Instrument Co., Inc. | 1992-12-01 |
| MICROMATE 196 MODEL A961960 (K901808) | Packard Instrument Co., Inc. | 1990-06-20 |
| IMMULON 1,2,3,AND 4 DIVIDASTRIPS TM (K894645) | Dynatech Laboratories, Inc. | 1989-10-17 |
| MULTI-PROBE HEAD PLUS (K892369) | Hamilton Co. | 1989-06-02 |
| GENETIC SYSTEMS MICROPLATE WASHER (K891768) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS MICROPLATE STRIP WASHER (K891766) | Genetic Systems Corp. | 1989-05-01 |
| GENETIC SYSTEMS PIPETTOR/DILUTOR (K891765) | Genetic Systems Corp. | 1989-05-01 |
| BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403 (K884125) | Bio-Tek Instruments, Inc. | 1988-12-02 |
| DYNATECH MR 250 MANUAL MICROELISA READER (K874598) | Dynatech Laboratories, Inc. | 1987-11-20 |
| MICROPLATE AUTO-WASHER (MOTORIZED STAGE) (K873542) | Genetic Systems Corp. | 1987-09-23 |
| MICROLAB AT (K871945) | Hamilton Co. | 1987-05-29 |
| CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100 (K863423) | Plastic Injectors, Inc. | 1986-09-16 |
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 |