The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Precinorm Tdm Controls.
| Device ID | K971060 |
| 510k Number | K971060 |
| Device Name: | PRECINORM TDM CONTROLS |
| Classification | Drug Mixture Control Materials |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-24 |
| Decision Date | 1997-07-07 |
| Summary: | summary |