Microelisa Minireader II
FDA 510(k) K830200 · Dynatech Corp.
510(k) numberK830200
Submission
- Device name
- Microelisa Minireader II
- Applicant
- Dynatech Corp.
Mchenry, IL, US - Received
- January 20, 1983
- Decision date
- February 16, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LBI – Unit, Neonatal Phototherapy
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5700
- Specialty
- General Hospital
Other 510(k)s with product code LBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251308 | SnugLit(TM) Wearable Phototherapy System (SNGL-01-US)LBI · Traditional | Thera B Medical Products | 01/15/2026SE |
| K243372 | BiliWrapLBI · Traditional | Gerium Medical, Ltd. | 05/29/2025SE |
| K210289 | Infant Phototherapy EquipmentLBI · Traditional | Bistos Co., Ltd. | 05/28/2021SE |
| K200031 | Neonatal Phototherapy SystemLBI · Traditional | Avalon Biomedical (Shenzhen) Limited | 10/05/2020SE |
| K190899 | bili-hutLBI · Traditional | Little Sparrows Technologies, Inc. | 09/05/2019SE |
| K182178 | neoBLUE blanket LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/13/2018SE |
| K172656 | BiliLuxLBI · Traditional | Draeger Medical Systems, Inc. | 05/01/2018SE |
| K170585 | SkylifeLBI · Traditional | Neolight, LLC | 10/27/2017SE |
| K163526 | Bilicocoon Phototherapy SystemLBI · Traditional | Neomedlight | 10/06/2017SE |
| K160745 | neoBLUE compact LED Phototherapy SystemLBI · Traditional | Natus Medical Incorporated | 12/12/2016SE |
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| K854603 | Multi Mash 2000LIB · Traditional | 12/06/1985SE |
| K854602 | Mini Mash 2000LIB · Traditional | 12/06/1985SE |
| K832117 | Immulon Substrate Removawell StripsLIB · Traditional | 08/08/1983SE |
| K823787 | Handi-WashLIB · Traditional | 03/09/1983SE |
| K823833 | Micro Stix #011-010-5000 & HOLDER#5100LIB · Traditional | 03/08/1983SE |
| K823773 | Provial II #006-010-0201KDT · Traditional | 01/21/1983SE |
| K823557 | Removawell Plate LidLIB · Traditional | 12/28/1982SE |
| K822962 | Microfluor B Removawell StripsLIB · Traditional | 11/16/1982SE |
Questions and answers
When was Microelisa Minireader II cleared by the FDA?
Microelisa Minireader II (K830200) received a 510(k) decision of Substantially Equivalent on February 16, 1983, 27 days after the submission was received.
What is the product code of K830200?
The FDA product code is LBI – Unit, Neonatal Phototherapy, a Class II (moderate risk) device regulated under 21 CFR 880.5700.