Access Testosterone
Beckman Coulter, Inc. · Clinical Chemistry
Open FDA's page for this record- Third party flag
- N
- City
- Chaska
- Advisory committee description
- Clinical Chemistry
- Address 1
- 1000 Lake Hazeltine Dr.
- Statement or summary
- Summary
- Product code
- CDZ
- Zip code
- 55318
- Applicant
- Beckman Coulter, Inc.
- Decision date
- 2023-01-13
- Decision code
- SESE
- Country code
- US
- Device name
- Access Testosterone
- Advisory committee
- CH
- Contact
- Kuljeet Kaur
- K number
- K223405
- State
- MN
- Date received
- 2022-11-09
- Review advisory committee
- CH
- Postal code
- 55318
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Radioimmunoassay, Testosterones And Dihydrotestosterone
- Medical specialty description
- Clinical Chemistry
- Regulation number
- 862.1680
- Device class
- 1
- Registration number
- 2432235, 3003030793, 2182595, 3005542422, 1219913, 8023018, 1063851, 8032314, 3011989923, 2018685, 3003559191, 2419955, 3022178699, 3005529799, 2032682, 3006198300, 2245285, 2032087, 3005333358, 3002642396, 2517506, 3007361513, 3007349751, 1036362, 1827821, 2122870, 1415939, 3010324880, 3005984081, 9615037, 9710337, 2250051, 3002809144, 9610126, 3009092698, 3002806944, 1319681, 3007118747, 1832216, 2020726 +17 more
- FEI number
- 1000442352, 2432235, 3003030793, 2182595, 3005542422, 3004185580, 1000136573, 1219913, 3011989923, 2018685, 3003559191, 2419955, 3022178699, 3005529799, 3002806557, 3006198300, 2245285, 3002807272, 3005333358, 3002642396, 2517506, 3003261083, 3007361513, 3000717645, 3007349751, 1036362, 1000121039, 1827821, 2122870, 3002806808, 3003952975, 1415939, 3010324880, 3007019572, 3005984081, 3003355251, 1000306617, 2250051, 3002809144, 3007118747 +17 more