Immulon 1 Eia Tubes, Immulon 2 Eia Tubes
FDA 510(k) K854423 · Dynatech Laboratories, Inc.
510(k) numberK854423
Submission
- Device name
- Immulon 1 Eia Tubes, Immulon 2 Eia Tubes
- Applicant
- Dynatech Laboratories, Inc.
Alexandria, VA, US - Received
- November 5, 1985
- Decision date
- November 20, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LIB – Device, General Purpose, Microbiology, Diagnostic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
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| K864249 | Normal Saline SterileLIB · Traditional | Mds Laboratories, Inc. | 03/31/1987SE |
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| K862112 | Microscope SlidesLIB · Traditional | Abco Dealers, Inc. | 06/13/1986SE |
| K854604 | Auto MashLIB · Traditional | Dynatech Corp. | 12/06/1985SE |
| K854603 | Multi Mash 2000LIB · Traditional | Dynatech Corp. | 12/06/1985SE |
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|---|---|---|
| K962265 | MLX Microtiter Plate LuminometerJSE · Traditional | 07/25/1996SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | 11/02/1994SE |
| 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 |
| K894645 | Immulon 1,2,3,AND 4 Dividastrips TMJTC · Traditional | 10/17/1989SE |
| K894687 | Dynatech MR 5000, Catalog #011-976-0600JJQ · Traditional | 08/31/1989SE |
Questions and answers
When was Immulon 1 Eia Tubes, Immulon 2 Eia Tubes cleared by the FDA?
Immulon 1 Eia Tubes, Immulon 2 Eia Tubes (K854423) received a 510(k) decision of Substantially Equivalent on November 20, 1985, 15 days after the submission was received.
What is the product code of K854423?
The FDA product code is LIB – Device, General Purpose, Microbiology, Diagnostic, a Class I (low risk) device regulated under 21 CFR 866.2660.