510(k) K860645
- Device
- Electrophoresis Data Center (edc)
- Applicant
- HELENA LABORATORIES
- 510(k) number
- K860645
- Product code
- JQT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1986-12-17
- Date received
- 1986-02-20
- Regulation
- 862.2400
- Classification name
- Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- BARBARA WARREN
- Address
- 1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704
FDA Registration Numbers#
- 3005174594
- 2027969
- 3029916095
- 3007361513
- 8030978
- 3003268355
- 3004181478
- 3010800486
- 3023162659
- 1644474
- 8023024
- 3004987297
- 3004201275
- 1219029
- 3027645317
- 9613069
- 3007118747
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JQT#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K111356 | ASIMANAGER - AT | Arlington Scientific, Inc. | 2011-11-09 |
| K944185 | ISOSCAN | Isolab, Inc. | 1994-11-17 |
| K915332 | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | 1992-02-18 |
| K885254 | TARGET READER | V-Tech, Inc. | 1989-01-27 |
| K862956 | ICON READER | Hybritech, Inc. | 1986-08-19 |
| K853734 | APOLLO DENSITOMETER | Astral Medical Systems | 1985-09-25 |
| K851154 | ELECTROPHORESIS APPARATUS, FOR CLINICAL USE 160,18 | Astral Medical Systems | 1985-05-13 |
| K850617 | CORNING 780 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | 1985-03-12 |
| K850260 | GLEMAN ACD-2020 AUTOMATIC COMPUTING DENSITOMETER | Gelman Sciences, Inc. | 1985-02-27 |
| K842313 | ELVI 146 SEROSCAN | Logos Scientific, Inc. | 1984-09-10 |
| K842056 | ELVI 165 PROTEO SEROSKOP | Logos Scientific, Inc. | 1984-06-22 |
| K810619 | 710 FLUOROMETER/DENSITOMETER | Corning Medical & Scientific | 1981-03-27 |
| K803240 | CORNING 760 FLUOROMETER/DENSITOMETER | Transidyne General Corp. | 1981-01-09 |
| K780901 | AUTOMATED ELECTROPHORESIS SYSTEM | Olympus Corp. | 1978-06-28 |
| K780318 | MODULAR SCANNING DENSITOMETER SYS. | Transidyne General Corp. | 1978-04-12 |