MULTI-PROBE HEAD PLUS
FDA 510(k) clearance K892369 · decided 1989-06-02
Clearance details
- K-number
- K892369
- Device name
- MULTI-PROBE HEAD PLUS
- Applicant
- Hamilton Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-04-06
- Decision date
- 1989-06-02
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JTC
- Device class
- 1
- Regulation number
- 866.2500
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Reno, NV, 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 |
| 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 |
| WASHER 500 MICROELISA SYSTEM (K884695) | Organon Teknika Corp. | 1988-12-13 |
| 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.