510(k) K180202
- Device
- Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator By Immuno Concepts
- Applicant
- Immuno Concepts, NA, Ltd.
- 510(k) number
- K180202
- Product code
- DBL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2018-10-19
- Date received
- 2018-01-24
- Regulation
- 866.5660
- Classification name
- Multiple Autoantibodies, Indirect Immunofluorescent, Antigen, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Eric S Hoy
- Address
- 9825 Goethe Rd., Suite #350 Sacramento CA US 95827 95827
FDA Registration Numbers#
- 1032347
- 2918768
- 2026994
- 3012348571
- 2242436
- 2029372
- 3015376545
- 2245451
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DBL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980312 | NOVA LITE ENDOMYSIAL | Inova Diagnostics, Inc. | 1998-04-02 |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | 1998-02-17 |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Euro-Diagnostica AB | 1997-10-29 |
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | 1997-05-23 |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | 1996-11-07 |
| K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT | The Binding Site, Ltd. | 1996-04-23 |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | Scimedx Corp. | 1996-04-10 |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | Light Diagnostics | 1995-03-06 |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | Light Diagnostics | 1995-03-06 |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | 1994-09-26 |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-06-09 |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | 1991-09-10 |
| K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | Medica Corp. | 1990-07-09 |
| K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | Immco Diagnostics, Inc. | 1989-03-22 |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | 1989-03-22 |
Legacy Summary#
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FDA Review#
Decision Summary