The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Enzymun-test Psa.
| Device ID | K965085 |
| 510k Number | K965085 |
| Device Name: | ENZYMUN-TEST PSA |
| Classification | Prostate-specific Antigen (psa) For Management Of Prostate Cancers |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Leeann Chambers, Rac |
| Correspondent | Leeann Chambers, Rac BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | LTJ |
| CFR Regulation Number | 866.6010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-19 |
| Decision Date | 1997-03-19 |
| Summary: | summary |