510(k) K780792
- Device
- Testosterone Radioimmunoassay Kit 125i
- Applicant
- THE UPJOHN CO.
- 510(k) number
- K780792
- Product code
- CDZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1978-06-13
- Date received
- 1978-05-15
- Regulation
- 862.1680
- Classification name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3004192065
- 2032087
- 2517506
- 2432235
- 3007111389
- 2018685
- 3005333358
- 3006198300
- 3022178699
- 3007349751
- 3011989923
- 3002806944
- 3000308930
- 8010132
- 1415939
- 3003030793
- 3002800697
- 3002809144
- 3007361513
- 2032682
- 3002642396
- 2029372
- 9610126
- 2245285
- 8020888
- 1036362
- 3010324880
- 8032314
- 8031673
- 3012963943
- 1832216
- 2032839
- 3009092698
- 2020726
- 1827821
- 2250051
- 8021924
- 3033967997
- 3005984081
- 8023018
- 3003559191
- 1063851
- 2122870
- 9615037
- 3005542422
- 3005529799
- 9610746
- 9710337
- 9612316
- 1222302
- 2182595
- 2133982
- 2419955
- 3007118747
- 1219913
- 1319681
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CDZ#
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| K191350 | ACTIVE® Free Testosterone RIA | Immunotech S.R.O. | 2019-12-20 |
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| K190121 | IDS SHBG | Immunodiagnostic Systems , Ltd. | 2019-06-17 |
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| K181017 | Free Testosterone AccuBind ELISA Test System | Monobind, Inc. | 2018-07-20 |
| K153577 | FREND Testosterone Test System | Nanoentek USA, Inc. | 2016-10-14 |
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| K151529 | Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-02-11 |
| K152185 | ARCHITECT SHBG | Biokit, S.A. | 2016-02-11 |