ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
FDA 510(k) clearance K944191 · decided 1995-03-06
Clearance details
- K-number
- K944191
- Device name
- ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER
- Applicant
- Light Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1994-08-29
- Decision date
- 1995-03-06
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- DBL
- Device class
- 2
- Regulation number
- 866.5660
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Histofluor Rodent LKS Fluorescent Antibody Test System, Image Navigator by Immuno Concepts (K180202) | Immuno Concepts, N.A. , Ltd. | 2018-10-19 |
| NOVA LITE ENDOMYSIAL (K980312) | Inova Diagnostics, Inc. | 1998-04-02 |
| WIELISA ANTI-GBM TEST SYSTEM (K974169) | Wieslab AB | 1998-02-17 |
| IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT (K971464) | Euro-Diagnostica AB | 1997-10-29 |
| MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT (K971658) | Jay H. Geller | 1997-05-23 |
| DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT (K963525) | Shield Diagnostics, Ltd. | 1996-11-07 |
| RIT LIVER, KIDNEY, STOMACH IFA KIT (K955431) | The Binding Site, Ltd. | 1996-04-23 |
| EIA KIT FOR THE DETECTION OF GBM ANTIBODIES (K953495) | Scimedx Corp. | 1996-04-10 |
| ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER (K944192) | Light Diagnostics | 1995-03-06 |
| ANTI-RETICULIN ANTIBODY (ARA) TEST (K913360) | Immco Diagnostics, Inc. | 1994-09-26 |
| ANTI-ENDOMYSIAL ANTIBODY TEST (K912551) | Immco Diagnostics, Inc. | 1993-06-09 |
| ANTI-GBM ANTIBODIES QUANTITATIVE KIT (K904181) | Biochemical Diagnostic, Inc. | 1991-09-10 |
Recalls involving this device
No recalls on record reference this clearance.