510(k) K052359
- Device
- IBL CORTISOL LIA TEST KIT
- Applicant
- Lehnus & Associates Consulting
- 510(k) number
- K052359
- Product code
- CGR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2005-10-03
- Date received
- 2005-08-26
- Regulation
- 862.1205
- Classification name
- Radioimmunoassay, Cortisol
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- N
Applicant Contact#
- Contact
- Gary Lehnus
- Address
- 150 Cherry Ln. Rd. East Stroudsburg PA US 18301 18301
FDA Registration Numbers#
- 3006198300
- 3002800697
- 9612296
- 2245285
- 2432235
- 3022178699
- 3012963943
- 2250051
- 3007118747
- 2020726
- 1036362
- 2122870
- 3011989923
- 3002642396
- 3007111389
- 1319681
- 8021924
- 3000308930
- 3002806944
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CGR#
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|---|---|---|---|
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| K062626 | CORTISOL ELISA | Ibl-Hamburg GmbH | 2006-12-20 |
| K060480 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL REAGENT PACK AND CALIBRATORS AND METABOLISM CONTROLS | Ortho-Clinical Diagnostics | 2006-07-03 |
| K050202 | CORTISOL AND CORTISOL CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS | Beckman Coulter, Inc. | 2005-02-09 |
| K042689 | NICHOLS ADVANTAGE CORTISOL | Nichols Institute Diagnostics | 2004-12-09 |
| K010790 | CORTISOL LIA | Kmi Diagnostics, Inc. | 2002-01-29 |
| K984520 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL IMMUNOASSAY, MODEL 62-7005 | Nichols Institute Diagnostics | 1999-02-05 |
| K983990 | VITROS IMMUNODIAGNOSTIC PRODUCTS CORTISOL ASSAY | Ortho-Clinical Diagnostics, Inc. | 1998-12-29 |
| K962208 | NICHOLS ADVANTAGE CHEMILUMINESCENCE CORTISOL KIT | Nichols Institute Diagnostics | 1997-04-08 |
| K954733 | ACCESS CORTISOL ASSAY (MODIFICATION) | Bio-Rad Laboratories, Inc. | 1995-12-05 |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-05-05 |