The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Elecsys Calcheck Hcg.
| Device ID | K963165 |
| 510k Number | K963165 |
| Device Name: | ELECSYS CALCHECK HCG |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Contact | John D Stevens, Rac |
| Correspondent | John D Stevens, Rac BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. P.O. BOX 50457 Indianapolis, IN 46250 -0457 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-14 |
| Decision Date | 1996-08-30 |
| Summary: | summary |