This page includes the latest FDA filings for Horiba Instruments Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 2086725 |
| FEI Number | 3002698356 |
| Name | HORIBA INSTRUMENTS INCORPORATED |
| Owner & Operator | HORIBA ABX SAS |
| Contact Address | PARC EUROMEDECINE RUE DU CADUCEE, BP 7290 MONTPELLIER FR-NOTA 34184 FR |
| Registration Status | 1 |
| Initial Importer | Y |
| Registration Expiration | 2020-04-25 |
| Registration Address | 9755 Research Dr IRVINE, CA 92618 US |
| Establishment Type | Manufacture Medical Device |
Device Company | Device | Date |
|---|---|---|
| HORIBA INSTRUMENTS INCORPORATED | Pointe HbA1c for the BS480 14-H7546-160 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe Direct Bilirubin for BS480 14-HB936-200 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe Creatinine for BS480 14-C7539-432 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe Creatine Kinase for BS480 14-C7522-220 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe Creatinine Enzymatic on BS480 14-C7548-216 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe BUN on BS480 14-B7552-600 | 2025-10-02 |
| HORIBA INSTRUMENTS INCORPORATED | Pointe ALT for the BS480 14-A7526-375 | 2025-10-02 |
HORIBA INSTRUMENTS INCORPORATED [HORIBA ABX SAS] | Novel Corona Virus (2019-nCoV) IgG/IgM Antibody Detection kit | 2020-03-26 |
HORIBA INSTRUMENTS INCORPORATED [HORIBA ABX SAS] | COVID-19 IgG/IgM Antibodies Rapid Test | 2020-03-26 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL CRP 5302042207 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL CRP 5302042206 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL CRP 5302042205 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOCAL 5300100152 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | DIFFTROL 5300100147 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | DIFFTROL 5300100142 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | DIFFTROL 5300100141 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | DIFFTROL 5300100112 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL RETIC 5300100075 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL RETIC 5300000284 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL 16 5300000283 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL 16 5300000278 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOTROL 16 5300000277 | 2018-03-29 |
| HORIBA INSTRUMENTS INCORPORATED | MINOCAL 5300000276 | 2018-03-29 |
HORIBA INSTRUMENTS, INC. | ELECTROLYTE ANALYZER SERA-252 | 1985-12-04 |
HORIBA INSTRUMENTS, INC. | SERA-210 ELECTROLYTE ANALYZER | 1985-09-03 |
HORIBA INSTRUMENTS, INC. | MODIFY ELECTROLYTE ANALYZER MODEL SERA-210 | 1985-01-08 |
HORIBA INSTRUMENTS, INC. | ELECTROLYTE ANALYZER SERA-210 | 1984-06-22 |
HORIBA INSTRUMENTS, INC. | SERA-250 | 1984-04-06 |
| Import ID | Shipment | Cargo Description | Quantity |
|---|---|---|---|
| 20200909118954 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | MOTOR DYNO 482KW HS CODE-850153 | 2 CAS |
| 2020072136875 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | AC COMPACT MOTOR HS CODE-850153 | 1 PKG |
| 2020071859751 | Bremerhaven,Federal Republic of Germany -> Norfolk, Virginia | AC COMPACT MOTOR HS CODE-850153 | 1 PKG |
| 2020063060168 | Bremerhaven,Federal Republic of Germany -> New York/Newark Area, Newark, New Jersey | CONVERTER FANS HS CODE-850153 | 6 CAS |
| 2020050826674 | Tokyo ,Japan -> Los Angeles, California | PHYSICAL CHEMICAL INSTRUMENT OR APPARATUS | 12 PKG |
| 2020050145378 | Tokyo ,Japan -> Los Angeles, California | PHYSICAL CHEMICAL INSTRUMENT OR APPARATUS | 12 PKG |
| 202003071061 | FOS Sur Mer,France -> Long Beach, California | LABORATORY REAGENTS FOR MEDICAL MATERIALS | 20 PKG |
| 202002015654 | FOS Sur Mer,France -> Long Beach, California | LABORATORY REAGENTS FOR MEDICAL MATERIALS COD E SCAC SHKK HBL NR FRLYS0000010055 | 22 PCS |