FDA Registration
Active
🇰🇷 South Korea
BODITECH MED INC.
Reg #: 3009491259
·
FEI: 3009491259
·
Expires 2026
Products
15
Proprietary Names
29
Establishment Types
2
Classifications
15
Registration Details
- Registration Name
- BODITECH MED INC.
- Registration Number
- 3009491259
- FEI Number
- 3009491259
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 43, Geodudanji 1-gil, Dongnae-myeon
- City
- Chuncheon Gangwon
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K170232
Owner / Operator
- Firm Name
- Boditech Med Inc.
- Operator Number
- 10046783
- Address
- 43, Geodudanji 1-gil, Dongnae-myeon
- City
- Chuncheon
- State
- Gangwon
- Postal Code
- 24398
- Country
- KR
- Correspondent
- Young Min Kim
US Agent
- Business Name
- Immunostics Inc.
- Contact Name
- Jung Hee Kim
- Address
- 38 industrial way east, suite 1
- City
- Eatontown
- State
- NJ
- ZIP
- 07724
- Country
- US
- [email protected]
- Phone
- 732 9180770
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Radioimmunoassay, Estradiol | CHP | Class 1 | Clinical Chemistry | No | 2026-02-05 |
| Radioimmunoassay, Luteinizing Hormone | CEP | Class 1 | Clinical Chemistry | No | 2023-06-12 |
| Radioimmunoassay, Follicle-Stimulating Hormone | CGJ | Class 1 | Clinical Chemistry | No | 2023-06-12 |
| Radioimmunoassay, Immunoreactive Insulin | CFP | Class 1 | Clinical Chemistry | No | 2025-03-04 |
| System, Hemoglobin, Automated | GKR | Class 2 | Hematology | No | 2018-11-28 |
| Control, Hemoglobin | GGM | Class 2 | Hematology | No | 2018-11-28 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | Class 1 | Clinical Chemistry | No | 2023-08-20 |
| Radioimmunoassay, C-Peptides Of Proinsulin | JKD | Class 1 | Clinical Chemistry | No | 2026-06-01 |
| Fluorometer, For Clinical Use | KHO | Class 1 | Clinical Chemistry | No | 2021-12-03 |
| Radioimmunoassay, Prolactin (Lactogen) | CFT | Class 1 | Clinical Chemistry | No | 2023-06-12 |
| Automated Occult Blood Analyzer | OOX | Class 2 | Hematology | No | 2014-05-12 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | Class 1 | Clinical Chemistry | No | 2014-05-12 |
| Radioimmunoassay, Thyroid-Stimulating Hormone | JLW | Class 2 | Clinical Chemistry | No | 2017-10-25 |
| System, Test, C-Reactive Protein | DCN | Class 2 | Immunology | No | 2016-06-16 |
| Radioimmunoassay, Progesterone | JLS | Class 1 | Clinical Chemistry | No | 2023-06-12 |
Proprietary Names
AFIAS Estradiol
AFIAS LH
AFIAS FSH
AFIAS Insulin
OneStep + Pro Hb Microcuvettes
OneStep + Pro Hb Analyzer
OneStep + Pro Hb Control
OneStep + Pro Hb Analyzer Starter Kit
hemochroma PLUS Analyzer
hemochroma PLUS Analyzer Promo Kit
hemochroma PLUS Control
hemochroma PLUS Optical System Check
hemochroma PLUS Microcuvettes
OneStep + Pro Hb Optical System Check
Boditech Hormone Control
AFIAS C-peptide
AFIAS-6
AFIAS-1
AFIAS-10
ichroma-50 PLUS
AFIAS-3
AFIAS PRL
i-CHROMA iFOB Controls
AFIAS-6/VB Analyzer
AFIAS-6/SP Analyzer
AFIAS TSH-VB
AFIAS TSH-SP
ichroma CRP
AFIAS Progesterone
Establishment Types
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)