FDA Registration
Active
🇺🇸 United States
BELAIR INSTRUMENT CO, LLC D/B/A AVANTIK
Reg #: 3014680809
·
FEI: 3014680809
·
Expires 2026
Products
11
Proprietary Names
6
Establishment Types
3
Classifications
11
Registration Details
- Registration Name
- BELAIR INSTRUMENT CO, LLC D/B/A AVANTIK
- Registration Number
- 3014680809
- FEI Number
- 3014680809
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 19 Chapin Road, Building C
- City
- Pine Brook
- State
- NJ
- ZIP
- 07058
- Country
- US
Regulatory Submissions
- 510(k) Number
- K093910
Owner / Operator
- Firm Name
- Belair Instrument Co, LLC d/b/a Avantik
- Operator Number
- 10057530
- Address
- 19 Chapin Road, Building C
- City
- Pine Brook
- State
- NJ
- Postal Code
- 07058
- Country
- US
- Correspondent
- Carl Suraci
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bath, Flotation, Tissue | IDY | Class 1 | Pathology | No | 2025-01-16 |
| Supplement, Culture Media | JSK | Class 1 | Microbiology | No | 2020-11-16 |
| Slides, Microscope | KEW | Class 1 | Pathology | No | 2018-05-30 |
| Coverslips, Microscope Slide | KES | Class 1 | Pathology | No | 2018-05-30 |
| Microtome, Cryostat | IDP | Class 1 | Pathology | No | 2021-05-27 |
| Microtome, Accessories | IDL | Class 1 | Pathology | No | 2018-05-30 |
| Micro Pipette | JRC | Class 1 | Clinical Chemistry | No | 2021-12-16 |
| Cassettes, Tissue | IDZ | Class 1 | Pathology | No | 2018-05-30 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2020-11-16 |
| Scalpel, One-Piece | GDX | Class 1 | General, Plastic Surgery | No | 2018-05-30 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | Class 2 | Clinical Chemistry | No | 2022-07-06 |
Proprietary Names
Avantik Tissue Floatation Bath
Avantik VTM-Kit
Avantik VTM
Avantik QS12 Cryostat
Sante Pipette Tips
Avantik Pipette Tip
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Develop Specifications But Do Not Manufacture At This Facility
Repack or Relabel Medical Device