510(k) K853048
- Device
- APO-SCREEN TEST SET FOR HDL-APOLIPOPTEIN A-1
- Applicant
- PHOTEC DIAGNOSTICS, INC.
- 510(k) number
- K853048
- Product code
- DER
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1985-08-28
- Date received
- 1985-07-19
- Regulation
- 866.5580
- Classification name
- Alpha-1-lipoprotein, Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES F MONGIARDO
- Address
- 101 E. Main St. Little Falls NJ US 07424 07424
FDA Registration Numbers#
- 2084025
- 3005094123
- 3006198300
- 9610126
- 3002809144
- 3003795116
- 3016438761
- 1181121
- 1000403749
- 3005333358
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DER #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K013249 | TINA-QUANT APOLIPOPROTEIN VER.2 | Roche Diagnostics Corp. | 2001-11-16 |
| K000921 | BAYER ADVIA IMS SYSTEM; 200 + 3 | Bayer Corp. | 2000-05-18 |
| K993354 | K-ASSAY APO B | Kamiya Biomedical Co. | 1999-10-28 |
| K993345 | K-ASSAY APO AI | Kamiya Biomedical Co. | 1999-10-25 |
| K990594 | INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 | Roche Diagnostics Corp. | 1999-04-14 |
| K983289 | APOLIPOPROTEIN A1 | Abbott Laboratories | 1999-01-29 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | 1997-08-01 |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 |
| K910553 | ROCHE APOLIPOPROTEIN STANDARD | Roche Diagnostic Systems, Inc. | 1991-05-08 |
| K904125 | UC IMU A | Eucardio Laboratory, Inc. | 1990-09-24 |
| K872078 | QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL | Solomon Park Research Laboratories | 1987-06-18 |
| K854875 | APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 | Photec Diagnostics, Inc. | 1986-01-24 |
| K851649 | APO A-I IMMUNOASSAY TEST SET FOR APOLIPOPROTEIN A1 | Photec Diagnostics, Inc. | 1985-06-05 |
| K840830 | VENTRIA APO A-1 ALPHA-1 LIPOTROTEIN | Ventrex Laboratories, Inc. | 1984-05-21 |
Legacy Summary#
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FDA Review#
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