Genetic Systems Microplate Strip Washer
FDA 510(k) K891766 · Genetic Systems Corp.
510(k) numberK891766
Submission
- Device name
- Genetic Systems Microplate Strip Washer
- Applicant
- Genetic Systems Corp.
Seattle, WA, US - Received
- March 24, 1989
- Decision date
- May 1, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTC – Device, Microtiter Diluting/Dispensing
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2500
- Specialty
- Microbiology
Other 510(k)s with product code JTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K924907 | Filtermate Universal HarvesterJTC · Traditional | Packard Instrument Co., Inc. | 12/01/1992SE |
| K901808 | Micromate 196 Model A961960JTC · Traditional | Packard Instrument Co., Inc. | 06/20/1990SE |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | Dynatech Laboratories, Inc. | 10/17/1989SE |
| K892369 | Multi-Probe Head PlusJTC · Traditional | Hamilton Co. | 06/02/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K884695 | Washer 500 Microelisa SystemJTC · Traditional | Organon Teknika Corp. | 12/13/1988SE |
| K884125 | Bio-Tek Automated Microplate Washer Model EL403JTC · Traditional | Bio-Tek Instruments, Inc. | 12/02/1988SE |
| K874598 | Dynatech MR 250 Manual Microelisa ReaderJTC · Traditional | Dynatech Laboratories, Inc. | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | Genetic Systems Corp. | 09/23/1987SE |
More from Genetic Systems Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K891767 | Genetic Systems Microplate ReaderJJQ · Traditional | 07/25/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | 05/01/1989SE |
| K891765 | Genetic Systems Pipettor/DilutorJTC · Traditional | 05/01/1989SE |
| K890768 | Pneumocystis Carinii Immunofluorescence Test KitLYF · Traditional | 03/21/1989SE |
| K873564 | Genetic Systems RSV Reagent Control SlidesLKT · Traditional | 11/20/1987SE |
| K873542 | Microplate Auto-Washer (Motorized Stage)JTC · Traditional | 09/23/1987SE |
| K870176 | Genetic Systems RSV Immunofluorescence Test KitLKT · Traditional | 07/16/1987SE |
| K870879 | Alanine Transaminase (Alt) Test KitCKA · Traditional | 03/19/1987SE |
| K863566 | GSC 1000JJQ · Traditional | 10/16/1986SE |
| K852237 | Legionella Immunofluorescent Antibody Test KitLHL · Traditional | 08/22/1985SE |
Questions and answers
When was Genetic Systems Microplate Strip Washer cleared by the FDA?
Genetic Systems Microplate Strip Washer (K891766) received a 510(k) decision of Substantially Equivalent on May 1, 1989, 38 days after the submission was received.
What is the product code of K891766?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.