510(k) K010550
- Device
- VIDAS TOTAL PROSTATE SPECIFIC ANTIGEN (TPSA), MODEL 30 428
- Applicant
- BIOMERIEUX, INC.
- 510(k) number
- K010550
- Product code
- LTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-04-24
- Date received
- 2001-02-26
- Regulation
- 866.6010
- Classification name
- Prostate-specific Antigen (psa) For Management Of Prostate Cancers
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Nancy Weaver
- Address
- 595 Anglum Rd. Hazelwood MO US 63042 63042
FDA Registration Numbers#
- 2032087
- 2517506
- 2432235
- 3007111389
- 3005333358
- 2025099
- 3006198300
- 3007349751
- 9680746
- 3002806944
- 3002800697
- 3002809144
- 3002642396
- 9610126
- 2245285
- 8020888
- 1036362
- 3010324880
- 8031673
- 3012963943
- 2032839
- 3009092698
- 3008344661
- 2020726
- 2250051
- 3005984081
- 2122870
- 3005529799
- 9612316
- 2521625
- 1219913
- 1319681
Source Documents#
Legacy Summary#
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FDA Review#
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