510(k) K980716
- Device
- ADVANTAGE CHEMILUMINESCENCE PROSTATE SPECIFIC ANTIGEN (PSA) IMMUNOASSAY
- Applicant
- NICHOLS INSTITUTE DIAGNOSTICS
- 510(k) number
- K980716
- Product code
- LTJ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-04-03
- Date received
- 1998-01-07
- 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
- DAVE SMITH
- Address
- 33051 Calle Aviador San Juan Capistrano CA US 92675 92675
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#
summary
FDA Review#
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