The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cedia N-acetylprocainamide Assay.
| Device ID | K963306 |
| 510k Number | K963306 |
| Device Name: | CEDIA N-ACETYLPROCAINAMIDE ASSAY |
| Classification | Enzyme Immunoassay, Procainamide |
| Applicant | BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Contact | Besty Soares-maddox |
| Correspondent | Besty Soares-maddox BOEHRINGER MANNHEIM CORP. 2400 BISSO LN. P.O. BOX 4117 Concord, CA 94524 -4117 |
| Product Code | LAR |
| CFR Regulation Number | 862.3320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-22 |
| Decision Date | 1996-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883005617 | K963306 | 000 |