Immulon 1,2,3,AND 4 Dividastrips TM
FDA 510(k) K894645 · Dynatech Laboratories, Inc.
510(k) numberK894645
Submission
- Device name
- Immulon 1,2,3,AND 4 Dividastrips TM
- Applicant
- Dynatech Laboratories, Inc.
Chantilly, VA, US - Received
- July 24, 1989
- Decision date
- October 17, 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
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| K892369 | Multi-Probe Head PlusJTC · Traditional | Hamilton Co. | 06/02/1989SE |
| K891768 | Genetic Systems Microplate WasherJTC · Traditional | Genetic Systems Corp. | 05/01/1989SE |
| K891766 | Genetic Systems Microplate Strip 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 |
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| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | 07/25/1996SE |
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| K943701 | MRX Microplate ReaderJJQ · Traditional | 10/20/1994SE |
| K923456 | Microlite Microtiter Plate Luminometer ML3000JJQ · Traditional | 10/13/1992SE |
| K915896 | Microlite Microtiter Plate Luminometer ML2250/MODIJJQ · Traditional | 05/04/1992SE |
| K920888 | Microlite Microtiter Plate Luminometer ML2200KHO · Traditional | 03/19/1992SE |
| K913590 | Microlite ML 1000 Microtiter Plate LuminometerJJQ · Traditional | 10/25/1991SE |
| K895313 | Microlite ML 1000 (Model 3) Microplate LuminometerJJQ · Traditional | 10/17/1989SE |
| K894687 | Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional | 08/31/1989SE |
| K890502 | Microlite Tube Luminometer #011-902-0000JJQ · Traditional | 02/27/1989SE |
Questions and answers
When was Immulon 1,2,3,AND 4 Dividastrips TM cleared by the FDA?
Immulon 1,2,3,AND 4 Dividastrips TM (K894645) received a 510(k) decision of Substantially Equivalent on October 17, 1989, 85 days after the submission was received.
What is the product code of K894645?
The FDA product code is JTC – Device, Microtiter Diluting/Dispensing, a Class I (low risk) device regulated under 21 CFR 866.2500.