The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Precicontrol Tumor Marker 1 And 2.
| Device ID | K972235 |
| 510k Number | K972235 |
| Device Name: | PRECICONTROL TUMOR MARKER 1 AND 2 |
| Classification | Multi-analyte Controls, All Kinds (assayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Contact | Leeann Chambers |
| Correspondent | Leeann Chambers BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis, IN 46250 -0457 |
| Product Code | JJY |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-16 |
| Decision Date | 1997-08-12 |
| Summary: | summary |