510(k) K010146
- Device
- ENA EIA KIT RANGE
- Applicant
- THE BINDING SITE, LTD.
- 510(k) number
- K010146
- Product code
- LLL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-03-01
- Date received
- 2001-01-17
- Regulation
- 866.5100
- Classification name
- Extractable Antinuclear Antibody, Antigen And Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAY H GELLER
- Address
- West Tower, Suite 4000 2425 W. Olympic Blvd. Santa Monica CA US 90404 90404
FDA Registration Numbers#
- 3003825930
- 1421346
- 3039353646
- 3002800697
- 8043792
- 3003268355
- 3004973408
- 2090110
- 2245285
- 9680745
- 2915274
- 3007118747
- 1181055
- 1222302
- 1318354
- 3007361513
- 2026994
- 9610566
- 3012348571
- 2242436
- 3015376545
- 2029372
- 2918768
- 3003935253
- 3007208259
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LLL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250666 | Alegria Flash CTD Screen | Zeus Scientific | 2025-10-22 |
| K250408 | Alegria Flash ENA Screen | Zeus Scientific | 2025-09-19 |
| K213403 | Aptiva CTD Essential Reagent | Inova Diagnostics, Inc. | 2023-09-29 |
| K190710 | EliA SymphonyS Immunoassay | Phadia AB | 2019-11-29 |
| K180975 | QUANTA Flash HMGCR Reagents | Inova Diagnostics, Inc. | 2018-06-25 |
| K152635 | QUANTA Flash Scl-70, QUANTA Flash Scl-70 Calibrators, QUANTA Flash Scl-70 Controls | Inova Diagnostics, Inc. | 2016-06-01 |
| K151429 | QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols | Inova Diagnostics, Inc. | 2016-02-12 |
| K142781 | ImmuLisa Enhanced SS-A (Ro) Antibody ELISA, ImmuLisa Enhanced SS-B (La) Antibody ELISA, ImmuLisa Enhanced Sm Antibody ELISA, ImmuLisa Enhanced RNP Antibody ELISA | Immco Diagnostics, Inc. | 2015-03-31 |
| K141328 | QUANTA FLASH RO60, QUANTA FLASH RO60 CALIBRATORS, QUANTA FLASH RO60 CONTROLS | Inova Diagnostics, Inc. | 2015-02-12 |
| K141210 | QUANTA FLASH SS-B, QUANTA FLASH SS-B CALIBRATORS, AND QUANTA FLASH SS-B CONTROLS | Inova Diagnostics, Inc. | 2015-01-29 |
| K122923 | QUANTA FLASH ENA7 | Inova Diagnostics, Inc. | 2013-05-07 |
| K112996 | EUROIMMUN ANTI-ENA POOL ELISA (IGG) | Euroimmun US | 2013-04-09 |
| K113143 | IMMULISA SCI-70 ANTIBODY ELISA | Immco Diagnostics, Inc. | 2011-12-02 |
| K102607 | FIDISTM CONNECTIVE 10, FIDISTM ANALYZER, CARIS | Biomedical Diagnostics (Bmd) SA | 2010-12-03 |
| K072149 | ELIA SYMPHONY IMMUNOASSAY, ANA CONTROL, MODEL 14-55508-01,83-1004-01 | Phadia US, Inc. | 2008-01-15 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases