510(k) K933180
- Device
- QUANTA LITE MITOCHONDRIA M2 ELISA
- Applicant
- INOVA DIAGNOSTICS, INC.
- 510(k) number
- K933180
- Product code
- DGC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-05
- Date received
- 1993-06-30
- Regulation
- 866.5510
- Classification name
- Ige, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BRYS MYERS
- Address
- 10451 Roselle St. San Diego CA US 92121 92121
FDA Registration Numbers#
- 3006198300
- 3002800697
- 2029275
- 3003985394
- 3004973408
- 9680746
- 2050012
- 9610806
- 2245285
- 3005333358
- 2432235
- 3022178699
- 1832216
- 9612316
- 1222302
- 1827821
- 9610566
- 8031673
- 3002637618
- 9610746
- 3004493545
- 3033967997
- 3005984081
- 2050010
- 3012471076
- 8020888
- 1219913
- 3005529799
- 2936856
- 9614373
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DGC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231151 | Kenota 1 Total IgE; Kenota 1 (instrument) | Kenota, Inc. | 2024-05-31 |
| K214068 | Quantia IgE | Biokit, S.A. | 2023-02-21 |
| K220178 | Total Immunoglobulin E (IgE) | Beckman Coulter, Inc. | 2022-03-23 |
| K193493 | ADVIA Centaur Total IgE (tIgE) | Siemens Healthcare Diagnostics, Inc. | 2020-01-15 |
| K161899 | ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP Total IgE Calibrators/Total IgE Curve Controls, ImmunoCAP Specific IgE Calibrator Strip/Specific IgE Curve Control Strip, ImmunoCAP Specific IgE Calibrators/Specific IgE Curve Controls | Phadia AB | 2016-07-28 |
| K133404 | IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL LMH | Phadia AB | 2014-02-24 |
| K063425 | DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH | Dade Behring, Inc. | 2007-02-15 |
| K050493 | QUANTIA IGE | Biokit, S.A. | 2005-08-16 |
| K042241 | K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C | Kamiya Biomedical Co. | 2004-12-10 |
| K034057 | LACRYTEST | Adiatec SA | 2004-03-09 |
| K032251 | IMMUNETECH TOTAL IGE SYSTEM | Immunetech Corporation | 2003-12-19 |
| K024210 | IMMAGE SYSTEMS TOTAL IMMUNOGLOBULIN E (IGE) REAGENT IMMAGE IGE CALIBRATOR | Beckman Coulter, Inc. | 2003-02-24 |
| K010855 | RANDOX IGE | Randox Laboratories, Ltd. | 2001-05-15 |
| K002560 | SHEEP ANTI-HUMAN IGE IMMUNOFIXATION GRADE KIT | The Binding Site, Ltd. | 2000-10-26 |
| K992528 | BIOCHECK IGE ELISA, MODEL BC-1035 | Biocheck, Inc. | 1999-09-21 |
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